Trial Outcomes & Findings for Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169) (NCT NCT03909165)

Last Updated: 2025-07-25

Results Overview

Pharmacokinetic (PK) blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine AUC0-inf for sugammadex. As pre-specified by the Statistical Analysis Plan (SAP) for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to \<27 days, 28 days to \<3 months, 3 to \<6 months, and 6 months to \< 2 years) for each dose (2 mg and 4 mg).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

145 participants

Primary outcome timeframe

Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose

Results posted on

2025-07-25

Participant Flow

145 pediatric participants between the ages of birth and \<2 years undergoing a procedure requiring a neuromuscular blocking agent (NMBA) for either moderate or deep neuromuscular blockade (NMB) were enrolled in this study. Participants were enrolled in 4 age cohorts: birth to 27 days, 28 days to \<3 months, 3 months to \<6 months, and 6 months to \<2 years.

50 participants were allocated to moderate block and reversal (2 mg/kg) or deep block and reversal (4 mg/kg) with sugammadex in Part A. 95 participants were randomized in Part B to moderate block and reversal (2 mg/kg) with sugammadex, deep block and reversal (4 mg/kg) with sugammadex, or moderate block and reversal with neostigmine (50 μg/kg).

Participant milestones

Participant milestones
Measure	Part A: Sugammadex 2 mg/kg Participants received a single intravenous (IV) bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg Participants received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part B: Sugammadex 2 mg/kg Participants received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part B: Sugammadex 4 mg/kg Participants received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part B: Neostigmine + (Glycopyrrolate or Atropine) Participants received a single IV bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg) based on availability and/or contraindications, for moderate NMB reversal.
Overall Study STARTED	16	34	31	32	32
Overall Study Treated	15	32	29	31	31
Overall Study COMPLETED	15	31	29	31	31
Overall Study NOT COMPLETED	1	3	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Sugammadex 2 mg/kg Participants received a single intravenous (IV) bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg Participants received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part B: Sugammadex 2 mg/kg Participants received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part B: Sugammadex 4 mg/kg Participants received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part B: Neostigmine + (Glycopyrrolate or Atropine) Participants received a single IV bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg) based on availability and/or contraindications, for moderate NMB reversal.
Overall Study Physician Decision	0	1	0	0	0
Overall Study Randomized By Mistake Without Study Treatment	0	0	0	0	1
Overall Study Withdrawal By Parent/Guardian	0	2	1	1	0
Overall Study Previous Drug Exposure	0	0	1	0	0
Overall Study Early Discharge	1	0	0	0	0

Baseline Characteristics

"Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Sugammadex 2 mg/kg n=16 Participants Participants received a single intravenous (IV) bolus of sugammadex at 2 mg/kg.	Part A: Sugammadex 4 mg/kg n=34 Participants Participants received a single IV bolus of sugammadex at 4 mg/kg.	Part B: Sugammadex 2 mg/kg n=31 Participants Participants received a single IV bolus of sugammadex at 2 mg/kg.	Part B: Sugammadex 4 mg/kg n=32 Participants Participants received a single IV bolus of sugammadex at 4 mg/kg.	Part B: Neostigmine + (Glycopyrrolate or Atropine) n=32 Participants Participants received a single IV bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg) based on availability and/or contraindications.	Total n=145 Participants Total of all reporting groups
Age, Continuous	195.9 days STANDARD_DEVIATION 193.4 • n=16 Participants	140.1 days STANDARD_DEVIATION 121.7 • n=34 Participants	157.9 days STANDARD_DEVIATION 171.8 • n=31 Participants	169.1 days STANDARD_DEVIATION 165.5 • n=32 Participants	174.3 days STANDARD_DEVIATION 192.7 • n=32 Participants	164.0 days STANDARD_DEVIATION 166.2 • n=145 Participants
Sex: Female, Male Female	7 Participants n=16 Participants	13 Participants n=34 Participants	5 Participants n=31 Participants	11 Participants n=32 Participants	12 Participants n=32 Participants	48 Participants n=145 Participants
Sex: Female, Male Male	9 Participants n=16 Participants	21 Participants n=34 Participants	26 Participants n=31 Participants	21 Participants n=32 Participants	20 Participants n=32 Participants	97 Participants n=145 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=16 Participants	6 Participants n=34 Participants	10 Participants n=31 Participants	7 Participants n=32 Participants	9 Participants n=32 Participants	35 Participants n=145 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=16 Participants	28 Participants n=34 Participants	21 Participants n=31 Participants	24 Participants n=32 Participants	23 Participants n=32 Participants	109 Participants n=145 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=16 Participants	0 Participants n=34 Participants	0 Participants n=31 Participants	1 Participants n=32 Participants	0 Participants n=32 Participants	1 Participants n=145 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=16 Participants	2 Participants n=34 Participants	4 Participants n=31 Participants	1 Participants n=32 Participants	4 Participants n=32 Participants	11 Participants n=145 Participants
Race (NIH/OMB) Asian	2 Participants n=16 Participants	4 Participants n=34 Participants	6 Participants n=31 Participants	8 Participants n=32 Participants	8 Participants n=32 Participants	28 Participants n=145 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=16 Participants	0 Participants n=34 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=32 Participants	0 Participants n=145 Participants
Race (NIH/OMB) Black or African American	0 Participants n=16 Participants	0 Participants n=34 Participants	0 Participants n=31 Participants	2 Participants n=32 Participants	1 Participants n=32 Participants	3 Participants n=145 Participants
Race (NIH/OMB) White	14 Participants n=16 Participants	28 Participants n=34 Participants	21 Participants n=31 Participants	20 Participants n=32 Participants	17 Participants n=32 Participants	100 Participants n=145 Participants
Race (NIH/OMB) More than one race	0 Participants n=16 Participants	0 Participants n=34 Participants	0 Participants n=31 Participants	1 Participants n=32 Participants	2 Participants n=32 Participants	3 Participants n=145 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=16 Participants	0 Participants n=34 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=32 Participants	0 Participants n=145 Participants
Protocol-defined Age Cohorts (All Participants As Treated Population) Birth to 27 days	4 Participants n=15 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	6 Participants n=32 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	7 Participants n=29 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	6 Participants n=31 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	5 Participants n=31 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	28 Participants n=138 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).
Protocol-defined Age Cohorts (All Participants As Treated Population) 28 days to < 3 months	3 Participants n=15 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	8 Participants n=32 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	6 Participants n=29 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	9 Participants n=31 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	9 Participants n=31 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	35 Participants n=138 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).
Protocol-defined Age Cohorts (All Participants As Treated Population) 3 months to < 6 months	2 Participants n=15 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	11 Participants n=32 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	8 Participants n=29 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	8 Participants n=31 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	8 Participants n=31 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	37 Participants n=138 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).
Protocol-defined Age Cohorts (All Participants As Treated Population) 6 months to < 2 years	6 Participants n=15 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	7 Participants n=32 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	8 Participants n=29 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	8 Participants n=31 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	9 Participants n=31 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).	38 Participants n=138 Participants • "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3).
Type of Neuromuscular Blocking Agent [NMBA] (All Participants As Treated Population) Rocuronium	14 Participants n=15 Participants • "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population.	25 Participants n=32 Participants • "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population.	21 Participants n=29 Participants • "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population.	19 Participants n=31 Participants • "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population.	19 Participants n=31 Participants • "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population.	98 Participants n=138 Participants • "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population.
Type of Neuromuscular Blocking Agent [NMBA] (All Participants As Treated Population) Vecuronium	1 Participants n=15 Participants • "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population.	7 Participants n=32 Participants • "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population.	8 Participants n=29 Participants • "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population.	12 Participants n=31 Participants • "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population.	12 Participants n=31 Participants • "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population.	40 Participants n=138 Participants • "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population.
EudraCT Age Categories Newborns (0-27 days)	4 Participants n=16 Participants	6 Participants n=34 Participants	7 Participants n=31 Participants	6 Participants n=32 Participants	6 Participants n=32 Participants	29 Participants n=145 Participants
EudraCT Age Categories Infants and toddlers (28 days-23 months)	12 Participants n=16 Participants	28 Participants n=34 Participants	24 Participants n=31 Participants	26 Participants n=32 Participants	26 Participants n=32 Participants	116 Participants n=145 Participants

PRIMARY outcome

Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose

Population: All pediatric participants in Part A who received at least 1 dose of sugammadex and had at least 5 samples at the time points of interest were analyzed per protocol by age cohort. One participant in the Sugammadex 2 mg/kg "3 months to \<6 months age cohort" was evaluated for PK but excluded from the APaT population due to missing IV dose information. Per protocol, Part B participants were not analyzed for PK.

Outcome measures

Outcome measures
Measure	Part A: Sugammadex 2 mg/kg [Birth to 27 Days] n=2 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [28 Days to <3 Months] n=3 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [3 to < 6 Months] n=3 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] n=5 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg [Birth to 27 Days] n=6 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] n=6 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [3 to < 6 Months] n=8 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] n=5 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) for Sugammadex	13.40 Hour (hr)*ug/mL NA = 95% confidence interval (CI) was not estimated for n\<3 due to insufficient data to support its protocol pre-specified calculation.	16.22 Hour (hr)*ug/mL Interval 12.14 to 21.67	11.50 Hour (hr)*ug/mL Interval 8.61 to 15.37	14.07 Hour (hr)*ug/mL Interval 11.24 to 17.61	39.09 Hour (hr)*ug/mL Interval 31.85 to 47.98	31.90 Hour (hr)*ug/mL Interval 25.99 to 39.16	24.75 Hour (hr)*ug/mL Interval 20.73 to 29.56	27.75 Hour (hr)*ug/mL Interval 22.17 to 34.74

PRIMARY outcome

Timeframe: Day 1: 2, 15, 30, and 60 minutes (1 hour) post-dose

PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine AUC0-1hr for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to \<27 days, 28 days to \<3 months, 3 to \<6 months, and 6 months to \< 2 years) for each dose (2 mg and 4 mg).

Outcome measures

Outcome measures
Measure	Part A: Sugammadex 2 mg/kg [Birth to 27 Days] n=3 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [28 Days to <3 Months] n=3 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [3 to < 6 Months] n=3 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] n=6 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg [Birth to 27 Days] n=6 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] n=7 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [3 to < 6 Months] n=9 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] n=7 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.
Part A: Area Under the Plasma Concentration Time Curve up to the Interpolated Concentration at 1 Hour Post Dose (AUC0-1hr) for Sugammadex	6.95 hr*ug/mL Interval 5.38 to 8.99	7.63 hr*ug/mL Interval 5.9 to 9.87	6.10 hr*ug/mL Interval 4.72 to 7.88	7.31 hr*ug/mL Interval 6.09 to 8.76	12.38 hr*ug/mL Interval 10.33 to 14.85	14.39 hr*ug/mL Interval 12.16 to 17.02	13.46 hr*ug/mL Interval 11.61 to 15.61	13.92 hr*ug/mL Interval 11.76 to 16.46

PRIMARY outcome

Timeframe: Day 1: 2, 15, 30, 60, and 240 minutes (4 hours) post-dose

PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine AUC0-4hr for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to \<27 days, 28 days to \<3 months, 3 to \<6 months, and 6 months to \< 2 years) for each dose (2 mg and 4 mg).

Outcome measures

Outcome measures
Measure	Part A: Sugammadex 2 mg/kg [Birth to 27 Days] n=2 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [28 Days to <3 Months] n=3 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [3 to < 6 Months] n=3 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] n=5 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg [Birth to 27 Days] n=6 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] n=6 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [3 to < 6 Months] n=8 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] n=6 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.
Part A: Area Under the Plasma Concentration Time Curve up to the Interpolated Concentration at 4 Hours Post Dose (AUC0-4hr) for Sugammadex	10.68 hr*ug/mL NA = 95% confidence interval (CI) was not estimated for n\<3 due to insufficient data to support its protocol pre-specified calculation.	13.99 hr*ug/mL Interval 10.67 to 18.33	10.13 hr*ug/mL Interval 7.73 to 13.27	12.57 hr*ug/mL Interval 10.19 to 15.5	27.79 hr*ug/mL Interval 22.95 to 33.64	27.16 hr*ug/mL Interval 22.43 to 32.89	21.51 hr*ug/mL Interval 18.23 to 25.39	22.43 hr*ug/mL Interval 18.52 to 27.15

PRIMARY outcome

Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose

PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine Cmax for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to \<27 days, 28 days to \<3 months, 3 to \<6 months, and 6 months to \< 2 years) for each dose (2 mg and 4 mg).

Outcome measures

Outcome measures
Measure	Part A: Sugammadex 2 mg/kg [Birth to 27 Days] n=4 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [28 Days to <3 Months] n=3 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [3 to < 6 Months] n=3 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] n=6 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg [Birth to 27 Days] n=6 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] n=8 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [3 to < 6 Months] n=9 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] n=7 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.
Part A: Maximum Plasma Concentration (Cmax) of Sugammadex	19.59 ug/mL Interval 14.15 to 27.13	21.18 ug/mL Interval 14.55 to 30.84	19.39 ug/mL Interval 13.32 to 28.23	20.99 ug/mL Interval 16.09 to 27.38	28.56 ug/mL Interval 21.89 to 37.25	30.38 ug/mL Interval 24.13 to 38.24	44.51 ug/mL Interval 35.83 to 55.29	40.86 ug/mL Interval 31.95 to 52.25

PRIMARY outcome

Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose

PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine CL for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to \<27 days, 28 days to \<3 months, 3 to \<6 months, and 6 months to \< 2 years) for each dose (2 mg and 4 mg).

Outcome measures

Outcome measures
Measure	Part A: Sugammadex 2 mg/kg [Birth to 27 Days] n=2 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [28 Days to <3 Months] n=3 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [3 to < 6 Months] n=3 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] n=5 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg [Birth to 27 Days] n=6 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] n=6 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [3 to < 6 Months] n=8 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] n=5 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.
Part A: Plasma Clearance (CL) of Sugammadex	0.43 Liters/hour NA = 95% confidence interval (CI) was not estimated for n\<3 due to insufficient data to support its protocol pre-specified calculation.	0.66 Liters/hour Interval 0.47 to 0.92	1.28 Liters/hour Interval 0.91 to 1.8	1.34 Liters/hour Interval 1.03 to 1.74	0.35 Liters/hour Interval 0.28 to 0.45	0.61 Liters/hour Interval 0.48 to 0.78	0.97 Liters/hour Interval 0.79 to 1.19	1.27 Liters/hour Interval 0.98 to 1.65

PRIMARY outcome

Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose

PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine Vd for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to \<27 days, 28 days to \<3 months, 3 to \<6 months, and 6 months to \< 2 years) for each dose (2 mg and 4 mg).

Outcome measures

Outcome measures
Measure	Part A: Sugammadex 2 mg/kg [Birth to 27 Days] n=2 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [28 Days to <3 Months] n=3 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [3 to < 6 Months] n=3 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] n=5 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg [Birth to 27 Days] n=6 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] n=6 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [3 to < 6 Months] n=8 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] n=5 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.
Part A: Apparent Volume of Distribution (Vd) for Sugammadex	1.14 Liters (L) NA = 95% confidence interval (CI) was not estimated for n\<3 due to insufficient data to support its protocol pre-specified calculation.	1.45 Liters (L) Interval 1.06 to 1.98	2.68 Liters (L) Interval 1.96 to 3.67	2.70 Liters (L) Interval 2.11 to 3.44	1.22 Liters (L) Interval 0.98 to 1.52	1.35 Liters (L) Interval 1.08 to 1.68	2.16 Liters (L) Interval 1.78 to 2.62	2.77 Liters (L) Interval 2.17 to 3.53

PRIMARY outcome

Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose

PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine Vss for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to \<27 days, 28 days to \<3 months, 3 to \<6 months, and 6 months to \< 2 years) for each dose (2 mg and 4 mg).

Outcome measures

Outcome measures
Measure	Part A: Sugammadex 2 mg/kg [Birth to 27 Days] n=2 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [28 Days to <3 Months] n=3 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [3 to < 6 Months] n=3 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] n=5 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg [Birth to 27 Days] n=6 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] n=6 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [3 to < 6 Months] n=8 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] n=5 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.
Apparent Volume of Distribution at Steady State (Vss) for Sugammadex	1.04 Liters (L) NA = 95% confidence interval (CI) was not estimated for n\<3 due to insufficient data to support its protocol pre-specified calculation.	1.23 Liters (L) Interval 0.94 to 1.6	2.07 Liters (L) Interval 1.59 to 2.7	2.14 Liters (L) Interval 1.74 to 2.63	1.11 Liters (L) Interval 0.92 to 1.34	1.18 Liters (L) Interval 0.98 to 1.43	1.69 Liters (L) Interval 1.43 to 1.98	2.18 Liters (L) Interval 1.77 to 2.68

PRIMARY outcome

Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose

PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine t½ for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to \<27 days, 28 days to \<3 months, 3 to \<6 months, and 6 months to \< 2 years) for each dose (2 mg and 4 mg).

Outcome measures

Outcome measures
Measure	Part A: Sugammadex 2 mg/kg [Birth to 27 Days] n=2 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [28 Days to <3 Months] n=3 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [3 to < 6 Months] n=3 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] n=5 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg [Birth to 27 Days] n=6 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] n=6 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [3 to < 6 Months] n=9 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] n=5 Participants Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.
Part A: Half-Life (t1/2) of Sugammadex in Plasma	1.84 Hours (h) Geometric Coefficient of Variation NA NA = 95% confidence interval (CI) was not estimated for n\<3 due to insufficient data to support its protocol pre-specified calculation.	1.52 Hours (h) Geometric Coefficient of Variation 20.21	1.45 Hours (h) Geometric Coefficient of Variation 28.57	1.40 Hours (h) Geometric Coefficient of Variation 24.25	2.39 Hours (h) Geometric Coefficient of Variation 27.34	1.53 Hours (h) Geometric Coefficient of Variation 16.42	1.51 Hours (h) Geometric Coefficient of Variation 28.79	1.51 Hours (h) Geometric Coefficient of Variation 19.46

PRIMARY outcome

Timeframe: Within Day 1

Population: All randomized participants in Part B who received ≥1 dose of study treatment for moderate NMB reversal (i.e. Sugammadex 2 mg/kg or Neostigmine + \[Glycopyrrolate or Atropine\]) and with available TTNMR data were analyzed. Per the protocol objective, no formal test for efficacy with comparison to neostigmine was done for Part A and Part B deep block, thus Part A and Part B 4 mg/kg participants were not included in this analysis.

Time to neuromuscular recovery was defined as the interval from administration of reversal agent to time to neuromuscular recovery. TTNMR could be assessed by 1 of 4 methods selected by the investigator, based on their judgment of what was technically feasible and clinically appropriate for the participant's procedure. These methods were inclusive of both clinical signs (head lift or hip flexion) and neuromuscular transmission monitoring using either a standard peripheral nerve stimulator or the technically challenging quantitative neuromuscular monitoring to train-of-four (TOF) ratio ≥0.9. As pre-specified by the protocol and SAP, TTNMR was analyzed only in Part B participants under the setting of moderate block for comparison of sugammadex 2 mg to neostigmine.

Outcome measures

Outcome measures
Measure	Part A: Sugammadex 2 mg/kg [Birth to 27 Days] Participants aged birth to 27 days received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [28 Days to <3 Months] Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [3 to < 6 Months] n=29 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg [Birth to 27 Days] n=31 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [3 to < 6 Months] Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.
Part B: Time to Neuromuscular Recovery (TTNMR) In Reversal of Moderate Block	—	—	1.4 Minutes 95% Confidence Interval 1.1 • Interval 1.1 to 2.0	—	4.4 Minutes 95% Confidence Interval 2.7 • Interval 2.7 to 7.9	—	—	—

PRIMARY outcome

Timeframe: Up to Day 7

Population: All enrolled/randomized participants from both Part A and Part B (combined per protocol) who received at least 1 dose of study treatment were analyzed.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified by the protocol and SAP, the primary analysis of safety combined data across Part A and Part B (and across age cohorts) and included all AEs that occurred up to 7 days post administration of study medication. The percentage of participants with an AE was reported by treatment and dose received.

Outcome measures

Outcome measures
Measure	Part A: Sugammadex 2 mg/kg [Birth to 27 Days] n=44 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [28 Days to <3 Months] n=63 Participants Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [3 to < 6 Months] n=31 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg [Birth to 27 Days] Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [3 to < 6 Months] Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.
Parts A and B: Percentage of Participants With Adverse Events (AEs) Up To 7 Days Post Administration of Study Medication	68.2 Percentage of Participants	68.3 Percentage of Participants	61.3 Percentage of Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Within Day 1

Population: All randomized participants in Part B who received ≥1 dose of study treatment for moderate NMB reversal (i.e. Sugammadex 2 mg/kg or Neostigmine + \[Glycopyrrolate or Atropine\]) were analyzed. Per the protocol objective, no formal test for efficacy with comparison to neostigmine was done for Part A and Part B deep block, thus Part A and Part B 4 mg/kg participants were not included in this analysis.

Time to extubation was defined as the interval from administration of reversal agent to removal of the endotracheal tube. Monitoring of time to extubation during Part B (moderate block) was achieved using the Extubation Readiness Assessment, which evaluated and documented clinically relevant elements including neuromuscular recovery, mental status, return of spontaneous ventilation, adequate oxygenation, hemodynamically stabile, and core body temperature with "Yes"/"No" answers (no overall score or direction attributed). The Operating Room anesthesiologist or other trained personnel were responsible for assessing extubation readiness beginning about 1 minute after study treatment administration and reassessing every 60 seconds until time of extubation readiness was achieved. As pre-specified by the protocol, Time to Extubation was analyzed only in Part B under setting of moderate block, and Part A participants were not included in this analysis.

Outcome measures

Outcome measures
Measure	Part A: Sugammadex 2 mg/kg [Birth to 27 Days] Participants aged birth to 27 days received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [28 Days to <3 Months] Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [3 to < 6 Months] n=29 Participants Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal.	Part A: Sugammadex 4 mg/kg [Birth to 27 Days] n=31 Participants Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] Participants aged 28 days to \<3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [3 to < 6 Months] Participants aged 3 to \< 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.	Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] Participants aged 6 months to \< 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal.
Part B: Time to Extubation In Reversal of Moderate Block	—	—	7.9 Minutes 95% Confidence Interval 5.7 • Interval 5.7 to 11.6	—	10.5 Minutes 95% Confidence Interval 7.9 • Interval 7.9 to 13.5	—	—	—

Adverse Events

Part A: Sugammadex 2 mg/kg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Part A: Sugammadex 4 mg/kg

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Part B: Sugammadex 2 mg/kg

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Part B: Sugammadex 4 mg/kg

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Part B: Neostigmine + (Glycopyrrolate or Atropine)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Sugammadex 2 mg/kg n=15 participants at risk Participants received a single intravenous (IV) bolus of sugammadex at 2 mg/kg.	Part A: Sugammadex 4 mg/kg n=32 participants at risk Participants received a single IV bolus of sugammadex at 4 mg/kg.	Part B: Sugammadex 2 mg/kg n=29 participants at risk Participants received a single IV bolus of sugammadex at 2 mg/kg.	Part B: Sugammadex 4 mg/kg n=31 participants at risk Participants received a single IV bolus of sugammadex at 4 mg/kg.	Part B: Neostigmine + (Glycopyrrolate or Atropine) n=31 participants at risk Participants received a single IV bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg) based on availability and/or contraindications.
Cardiac disorders Bradycardia	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/15 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.1% 1/32 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Infections and infestations Pyelonephritis	0.00% 0/15 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.2% 1/31 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Injury, poisoning and procedural complications Anaesthetic complication	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Nervous system disorders Cerebral haemorrhage	0.00% 0/15 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.4% 1/29 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Product Issues Device mechanical issue	0.00% 0/15 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.4% 1/29 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Renal and urinary disorders Urinoma	0.00% 0/15 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.4% 1/29 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.

Other adverse events

Other adverse events
Measure	Part A: Sugammadex 2 mg/kg n=15 participants at risk Participants received a single intravenous (IV) bolus of sugammadex at 2 mg/kg.	Part A: Sugammadex 4 mg/kg n=32 participants at risk Participants received a single IV bolus of sugammadex at 4 mg/kg.	Part B: Sugammadex 2 mg/kg n=29 participants at risk Participants received a single IV bolus of sugammadex at 2 mg/kg.	Part B: Sugammadex 4 mg/kg n=31 participants at risk Participants received a single IV bolus of sugammadex at 4 mg/kg.	Part B: Neostigmine + (Glycopyrrolate or Atropine) n=31 participants at risk Participants received a single IV bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg) based on availability and/or contraindications.
Blood and lymphatic system disorders Anaemia	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	6.9% 2/29 • Number of events 2 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Cardiac disorders Bradycardia	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	9.7% 3/31 • Number of events 3 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Cardiac disorders Tachycardia	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Gastrointestinal disorders Teething	0.00% 0/15 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	6.9% 2/29 • Number of events 2 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 2 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	10.3% 3/29 • Number of events 3 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	6.5% 2/31 • Number of events 2 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.2% 1/31 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
General disorders Pain	0.00% 0/15 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	6.9% 2/29 • Number of events 2 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	6.5% 2/31 • Number of events 2 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.2% 1/31 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
General disorders Pyrexia	13.3% 2/15 • Number of events 3 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.1% 1/32 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	6.9% 2/29 • Number of events 2 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	6.5% 2/31 • Number of events 2 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.2% 1/31 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Infections and infestations Device related sepsis	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Infections and infestations Postoperative wound infection	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Injury, poisoning and procedural complications Post procedural oedema	6.7% 1/15 • Number of events 2 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/15 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.1% 1/32 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	6.9% 2/29 • Number of events 2 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Injury, poisoning and procedural complications Procedural pain	46.7% 7/15 • Number of events 7 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	65.6% 21/32 • Number of events 22 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	37.9% 11/29 • Number of events 12 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	41.9% 13/31 • Number of events 13 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	32.3% 10/31 • Number of events 10 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Injury, poisoning and procedural complications Procedural vomiting	13.3% 2/15 • Number of events 2 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.1% 1/32 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.4% 1/29 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Bradypnoea	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	3.2% 1/31 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Irregular breathing	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory depression	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
Skin and subcutaneous tissue disorders Skin lesion	6.7% 1/15 • Number of events 1 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/32 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/29 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.	0.00% 0/31 • Up to Day 14 All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In accordance with standard editorial and ethical practice, the Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
Publication restrictions are in place

Restriction type: OTHER