Trial Outcomes & Findings for Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089) (NCT NCT03351608)
NCT ID: NCT03351608
Last Updated: 2021-02-05
Results Overview
The AUCo-∞ for sugammadex, defined as the area under the plasma concentration versus time plot, was determined in each Part A arm.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
288 participants
Primary outcome timeframe
2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose
Results posted on
2021-02-05
Participant Flow
Male and female participants 2 to \<17 years of age who are categorized as American Society of Anesthesiologists (ASA) Physical Class 1, 2, or 3 and had a planned medical and/or surgical procedure requiring moderate or deep neuromuscular blockade (NMB) with rocuronium (ROC) or vecuronium (VEC) that would allow for neuromuscular monitoring were recruited.
Participant milestones
| Measure |
Part A: Sugammadex 2 mg/kg
For moderate NMB reversal, a single intravenous (i.v.) bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to train-of-four (TOF) stimulations.
|
Part A: Sugammadex 4 mg
For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
|
Part B: Sugammadex 2 mg/kg
For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
|
Part B: Sugammadex 4 mg/kg
For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
|
Part B: Neostigmine + (Glycopyrrolate or Atropine)
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
23
|
35
|
176
|
35
|
|
Overall Study
Treated
|
18
|
22
|
33
|
169
|
34
|
|
Overall Study
COMPLETED
|
18
|
21
|
32
|
168
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
8
|
2
|
Reasons for withdrawal
| Measure |
Part A: Sugammadex 2 mg/kg
For moderate NMB reversal, a single intravenous (i.v.) bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to train-of-four (TOF) stimulations.
|
Part A: Sugammadex 4 mg
For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
|
Part B: Sugammadex 2 mg/kg
For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
|
Part B: Sugammadex 4 mg/kg
For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
|
Part B: Neostigmine + (Glycopyrrolate or Atropine)
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
2
|
1
|
|
Overall Study
Randomized by mistake, no treatment given
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by parent/guardian
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
1
|
3
|
0
|
Baseline Characteristics
Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)
Baseline characteristics by cohort
| Measure |
Part A: Sugammadex 2 mg/kg
n=19 Participants
For moderate NMB reversal, a single intravenous (i.v.) bolus of sugammadex (2 mg/kg) is given after the final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
|
Part A: Sugammadex 4 mg
n=23 Participants
For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) is given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
|
Part B: Sugammadex 2 mg/kg
n=35 Participants
For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) is given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
|
Part B: Sugammadex 4 mg/kg
n=176 Participants
For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) is given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
|
Part B: Neostigmine + (Glycopyrrolate or Atropine)
n=35 Participants
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) is given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
7.1 years
STANDARD_DEVIATION 4.7 • n=99 Participants
|
7.2 years
STANDARD_DEVIATION 5.0 • n=107 Participants
|
7.9 years
STANDARD_DEVIATION 4.4 • n=206 Participants
|
7.9 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
8.7 years
STANDARD_DEVIATION 4.4 • n=31 Participants
|
7.9 years
STANDARD_DEVIATION 4.4 • n=30 Participants
|
|
Age, Customized
Children (2-11 years)
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
132 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
214 Participants
n=30 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
74 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
156 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
81 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
132 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
161 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
257 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dosePopulation: All participants with ≥5 post-dosing samples available are included.
The AUCo-∞ for sugammadex, defined as the area under the plasma concentration versus time plot, was determined in each Part A arm.
Outcome measures
| Measure |
Part A: Sugammadex 2 mg (2 to <6 Years)
n=9 Participants
Participants in Part A receiving sugammadex 2 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 2 mg (6 to <12 Years)
n=5 Participants
Participants in Part A receiving sugammadex 2 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 2 mg (12 to <17 Years)
n=4 Participants
Participants in Part A receiving sugammadex 2 mg and who are 12 to \<17 years of age are included.
|
Part A: Sugammadex 4 mg (2 to <6 Years)
n=8 Participants
Participants in Part A receiving sugammadex 4 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 4 mg (6 to <12 Years)
n=6 Participants
Participants in Part A receiving sugammadex 4 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 4 mg (12 to <17 Years)
n=6 Participants
Participants in Part A receiving sugammadex 4 mg and who are 12 to \<17 years of age are included.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to Infinity (AUC0-∞) of Sugammadex [Part A]
|
14.1 hr*μg/mL
Geometric Coefficient of Variation 19.4
|
18.8 hr*μg/mL
Geometric Coefficient of Variation 27.4
|
27.6 hr*μg/mL
Geometric Coefficient of Variation 58.0
|
26.9 hr*μg/mL
Geometric Coefficient of Variation 18.5
|
38.2 hr*μg/mL
Geometric Coefficient of Variation 73.0
|
49.2 hr*μg/mL
Geometric Coefficient of Variation 20.1
|
PRIMARY outcome
Timeframe: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dosePopulation: All participants with ≥5 post-dosing samples available are included.
The CL of sugammadex, defined as the rate of elimination relative to plasma concentration, was determined in each Part A arm.
Outcome measures
| Measure |
Part A: Sugammadex 2 mg (2 to <6 Years)
n=9 Participants
Participants in Part A receiving sugammadex 2 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 2 mg (6 to <12 Years)
n=5 Participants
Participants in Part A receiving sugammadex 2 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 2 mg (12 to <17 Years)
n=4 Participants
Participants in Part A receiving sugammadex 2 mg and who are 12 to \<17 years of age are included.
|
Part A: Sugammadex 4 mg (2 to <6 Years)
n=8 Participants
Participants in Part A receiving sugammadex 4 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 4 mg (6 to <12 Years)
n=6 Participants
Participants in Part A receiving sugammadex 4 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 4 mg (12 to <17 Years)
n=6 Participants
Participants in Part A receiving sugammadex 4 mg and who are 12 to \<17 years of age are included.
|
|---|---|---|---|---|---|---|
|
Plasma Clearance (CL) of Sugammadex [Part A]
|
2.30 L/hr
Geometric Coefficient of Variation 21.4
|
3.58 L/hr
Geometric Coefficient of Variation 26.2
|
4.68 L/hr
Geometric Coefficient of Variation 52.5
|
2.26 L/hr
Geometric Coefficient of Variation 29.4
|
3.43 L/hr
Geometric Coefficient of Variation 105
|
5.69 L/hr
Geometric Coefficient of Variation 24.1
|
PRIMARY outcome
Timeframe: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dosePopulation: All participants with ≥5 post-dosing samples available are included.
The Vz of sugammadex, defined as the amount of drug administered relative to plasma concentrations, was determined in each Part A arm.
Outcome measures
| Measure |
Part A: Sugammadex 2 mg (2 to <6 Years)
n=9 Participants
Participants in Part A receiving sugammadex 2 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 2 mg (6 to <12 Years)
n=5 Participants
Participants in Part A receiving sugammadex 2 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 2 mg (12 to <17 Years)
n=4 Participants
Participants in Part A receiving sugammadex 2 mg and who are 12 to \<17 years of age are included.
|
Part A: Sugammadex 4 mg (2 to <6 Years)
n=8 Participants
Participants in Part A receiving sugammadex 4 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 4 mg (6 to <12 Years)
n=6 Participants
Participants in Part A receiving sugammadex 4 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 4 mg (12 to <17 Years)
n=6 Participants
Participants in Part A receiving sugammadex 4 mg and who are 12 to \<17 years of age are included.
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz) of Sugammadex [Part A]
|
3.58 Liters
Geometric Coefficient of Variation 21.3
|
6.65 Liters
Geometric Coefficient of Variation 33.5
|
10.8 Liters
Geometric Coefficient of Variation 34.8
|
4.00 Liters
Geometric Coefficient of Variation 37.7
|
8.22 Liters
Geometric Coefficient of Variation 82.9
|
12.3 Liters
Geometric Coefficient of Variation 35.9
|
PRIMARY outcome
Timeframe: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dosePopulation: All participants with ≥5 post-dosing samples available are included.
The Cmax of sugammadex, defined as the maximum plasma concentration, was determined in each Part A arm.
Outcome measures
| Measure |
Part A: Sugammadex 2 mg (2 to <6 Years)
n=9 Participants
Participants in Part A receiving sugammadex 2 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 2 mg (6 to <12 Years)
n=5 Participants
Participants in Part A receiving sugammadex 2 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 2 mg (12 to <17 Years)
n=4 Participants
Participants in Part A receiving sugammadex 2 mg and who are 12 to \<17 years of age are included.
|
Part A: Sugammadex 4 mg (2 to <6 Years)
n=8 Participants
Participants in Part A receiving sugammadex 4 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 4 mg (6 to <12 Years)
n=6 Participants
Participants in Part A receiving sugammadex 4 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 4 mg (12 to <17 Years)
n=6 Participants
Participants in Part A receiving sugammadex 4 mg and who are 12 to \<17 years of age are included.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Sugammadex [Part A]
|
17.5 µg/mL
Geometric Coefficient of Variation 33.1
|
32.2 µg/mL
Geometric Coefficient of Variation 15.6
|
41.3 µg/mL
Geometric Coefficient of Variation 85.8
|
47.1 µg/mL
Geometric Coefficient of Variation 22.1
|
51.6 µg/mL
Geometric Coefficient of Variation 69.2
|
61.9 µg/mL
Geometric Coefficient of Variation 13.5
|
PRIMARY outcome
Timeframe: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dosePopulation: All participants with ≥5 post-dosing samples available are included.
The t½ of sugammadex, defined as the time required for the plasma concentration to decrease to 50% of maximum, was determined in each Part A arm.
Outcome measures
| Measure |
Part A: Sugammadex 2 mg (2 to <6 Years)
n=9 Participants
Participants in Part A receiving sugammadex 2 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 2 mg (6 to <12 Years)
n=5 Participants
Participants in Part A receiving sugammadex 2 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 2 mg (12 to <17 Years)
n=4 Participants
Participants in Part A receiving sugammadex 2 mg and who are 12 to \<17 years of age are included.
|
Part A: Sugammadex 4 mg (2 to <6 Years)
n=8 Participants
Participants in Part A receiving sugammadex 4 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 4 mg (6 to <12 Years)
n=6 Participants
Participants in Part A receiving sugammadex 4 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 4 mg (12 to <17 Years)
n=6 Participants
Participants in Part A receiving sugammadex 4 mg and who are 12 to \<17 years of age are included.
|
|---|---|---|---|---|---|---|
|
Plasma Half-Life (t½) of Sugammadex [Part A]
|
1.15 Hours
Interval 0.964 to 1.64
|
1.19 Hours
Interval 1.01 to 1.71
|
1.49 Hours
Interval 1.17 to 1.91
|
1.12 Hours
Interval 0.922 to 1.78
|
1.56 Hours
Interval 1.21 to 3.06
|
1.51 Hours
Interval 1.2 to 1.91
|
PRIMARY outcome
Timeframe: Up to 7 daysPopulation: Each participant who received a dose of study drug is included.
The percentage of participants with ≥1 AE(s) for up to 7 days after treatment was determined for each treatment group, pooled according to treatment received. An AE is defined as any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated.
Outcome measures
| Measure |
Part A: Sugammadex 2 mg (2 to <6 Years)
n=34 Participants
Participants in Part A receiving sugammadex 2 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 2 mg (6 to <12 Years)
n=51 Participants
Participants in Part A receiving sugammadex 2 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 2 mg (12 to <17 Years)
n=191 Participants
Participants in Part A receiving sugammadex 2 mg and who are 12 to \<17 years of age are included.
|
Part A: Sugammadex 4 mg (2 to <6 Years)
Participants in Part A receiving sugammadex 4 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 4 mg (6 to <12 Years)
Participants in Part A receiving sugammadex 4 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 4 mg (12 to <17 Years)
Participants in Part A receiving sugammadex 4 mg and who are 12 to \<17 years of age are included.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥1 Adverse Event (AE) [Parts A and B]
|
97.1 Percentage of Participants
|
78.4 Percentage of Participants
|
74.9 Percentage of Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 30 minutes post-dosePopulation: All randomized participants in Part B who received ≥1 dose of study drug are included.
The time to recovery of TOF ratio to ≥0.9 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB. Per protocol, the efficacy analysis is based on comparison of the Part B: Sugammadex 2 mg arm versus the Part B: Neostigmine + (Glycopyrrolate or Atropine) arm.
Outcome measures
| Measure |
Part A: Sugammadex 2 mg (2 to <6 Years)
n=33 Participants
Participants in Part A receiving sugammadex 2 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 2 mg (6 to <12 Years)
n=169 Participants
Participants in Part A receiving sugammadex 2 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 2 mg (12 to <17 Years)
n=34 Participants
Participants in Part A receiving sugammadex 2 mg and who are 12 to \<17 years of age are included.
|
Part A: Sugammadex 4 mg (2 to <6 Years)
Participants in Part A receiving sugammadex 4 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 4 mg (6 to <12 Years)
Participants in Part A receiving sugammadex 4 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 4 mg (12 to <17 Years)
Participants in Part A receiving sugammadex 4 mg and who are 12 to \<17 years of age are included.
|
|---|---|---|---|---|---|---|
|
Time to Recovery of Participant Train-of-Four (TOF) Ratio to ≥0.9 [Part B]
|
1.6 Minutes
95% Confidence Interval 1.3 • Interval 1.3 to 2.0
|
1.9 Minutes
95% Confidence Interval 1.7 • Interval 1.7 to 2.2
|
7.5 Minutes
95% Confidence Interval 5.6 • Interval 5.6 to 10.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 minutes post-dosePopulation: All randomized participants in Part B who received ≥1 dose of study drug are included.
The time to recovery of TOF ratio to ≥0.7 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB.
Outcome measures
| Measure |
Part A: Sugammadex 2 mg (2 to <6 Years)
n=33 Participants
Participants in Part A receiving sugammadex 2 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 2 mg (6 to <12 Years)
n=169 Participants
Participants in Part A receiving sugammadex 2 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 2 mg (12 to <17 Years)
n=34 Participants
Participants in Part A receiving sugammadex 2 mg and who are 12 to \<17 years of age are included.
|
Part A: Sugammadex 4 mg (2 to <6 Years)
Participants in Part A receiving sugammadex 4 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 4 mg (6 to <12 Years)
Participants in Part A receiving sugammadex 4 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 4 mg (12 to <17 Years)
Participants in Part A receiving sugammadex 4 mg and who are 12 to \<17 years of age are included.
|
|---|---|---|---|---|---|---|
|
Time to Recovery of Participant TOF Ratio to ≥0.7 [Part B]
|
1.1 Minutes
95% Confidence Interval 0.9 • Interval 0.9 to 1.3
|
1.3 Minutes
95% Confidence Interval 1.1 • Interval 1.1 to 1.4
|
3.7 Minutes
95% Confidence Interval 2.9 • Interval 2.9 to 4.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 minutes post-dosePopulation: All randomized participants in Part B who received ≥1 dose of study drug are included.
The time to recovery of TOF ratio to ≥0.8 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB.
Outcome measures
| Measure |
Part A: Sugammadex 2 mg (2 to <6 Years)
n=33 Participants
Participants in Part A receiving sugammadex 2 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 2 mg (6 to <12 Years)
n=169 Participants
Participants in Part A receiving sugammadex 2 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 2 mg (12 to <17 Years)
n=34 Participants
Participants in Part A receiving sugammadex 2 mg and who are 12 to \<17 years of age are included.
|
Part A: Sugammadex 4 mg (2 to <6 Years)
Participants in Part A receiving sugammadex 4 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 4 mg (6 to <12 Years)
Participants in Part A receiving sugammadex 4 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 4 mg (12 to <17 Years)
Participants in Part A receiving sugammadex 4 mg and who are 12 to \<17 years of age are included.
|
|---|---|---|---|---|---|---|
|
Time to Recovery of Participant TOF Ratio to ≥0.8 [Part B]
|
1.3 Minutes
95% Confidence Interval 1.1 • Interval 1.1 to 1.6
|
1.5 Minutes
95% Confidence Interval 1.3 • Interval 1.3 to 1.7
|
5.0 Minutes
95% Confidence Interval 3.8 • Interval 3.8 to 6.7
|
—
|
—
|
—
|
Adverse Events
Part A: Sugammadex 2 mg (2 to <6 Years)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part A: Sugammadex 2 mg (6 to <12 Years)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Sugammadex 2 mg (12 to <17 Years)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Sugammadex 4 mg (2 to <6 Years)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part A: Sugammadex 4 mg (6 to <12 Years)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: Sugammadex 4 mg (12 to <17 Years)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B: Sugammadex 2 mg
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Part B: Sugammadex 4 mg
Serious events: 3 serious events
Other events: 117 other events
Deaths: 0 deaths
Part B: Neostigmine + (Glycopyrrolate or Atropine)
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Sugammadex 2 mg (2 to <6 Years)
n=9 participants at risk
Participants in Part A receiving sugammadex 2 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 2 mg (6 to <12 Years)
n=5 participants at risk
Participants in Part A receiving sugammadex 2 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 2 mg (12 to <17 Years)
n=4 participants at risk
Participants in Part A receiving sugammadex 2 mg and who are 12 to \<17 years of age are included.
|
Part A: Sugammadex 4 mg (2 to <6 Years)
n=10 participants at risk
Participants in Part A receiving sugammadex 4 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 4 mg (6 to <12 Years)
n=6 participants at risk
Participants in Part A receiving sugammadex 4 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 4 mg (12 to <17 Years)
n=6 participants at risk
Participants in Part A receiving sugammadex 4 mg and who are 12 to \<17 years of age are included.
|
Part B: Sugammadex 2 mg
n=33 participants at risk
For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
|
Part B: Sugammadex 4 mg
n=169 participants at risk
For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
|
Part B: Neostigmine + (Glycopyrrolate or Atropine)
n=34 participants at risk
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.59%
1/169 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.59%
1/169 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
3.0%
1/33 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.59%
1/169 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
3.0%
1/33 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
3.0%
1/33 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
2.9%
1/34 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
2.9%
1/34 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
Other adverse events
| Measure |
Part A: Sugammadex 2 mg (2 to <6 Years)
n=9 participants at risk
Participants in Part A receiving sugammadex 2 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 2 mg (6 to <12 Years)
n=5 participants at risk
Participants in Part A receiving sugammadex 2 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 2 mg (12 to <17 Years)
n=4 participants at risk
Participants in Part A receiving sugammadex 2 mg and who are 12 to \<17 years of age are included.
|
Part A: Sugammadex 4 mg (2 to <6 Years)
n=10 participants at risk
Participants in Part A receiving sugammadex 4 mg and who are 2 to \<6 years of age are included.
|
Part A: Sugammadex 4 mg (6 to <12 Years)
n=6 participants at risk
Participants in Part A receiving sugammadex 4 mg and who are 6 to \<12 years of age are included.
|
Part A: Sugammadex 4 mg (12 to <17 Years)
n=6 participants at risk
Participants in Part A receiving sugammadex 4 mg and who are 12 to \<17 years of age are included.
|
Part B: Sugammadex 2 mg
n=33 participants at risk
For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) was given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
|
Part B: Sugammadex 4 mg
n=169 participants at risk
For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
|
Part B: Neostigmine + (Glycopyrrolate or Atropine)
n=34 participants at risk
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as either glycopyrrolate (10 μg/kg) or atropine (20 µg/kg) was given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
11.1%
1/9 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
20.0%
1/5 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
10.0%
1/10 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
16.7%
1/6 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
16.7%
1/6 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
3.0%
1/33 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
5.3%
9/169 • Number of events 9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
8.8%
3/34 • Number of events 3 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
10.0%
1/10 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Cardiac disorders
Sinus bradycardia
|
11.1%
1/9 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
3.0%
1/33 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.59%
1/169 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
5.9%
2/34 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Eye disorders
Eye irritation
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
6.1%
2/33 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
16.7%
1/6 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.59%
1/169 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
20.0%
1/5 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.59%
1/169 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Mouth swelling
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
40.0%
2/5 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
10.0%
1/10 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
16.7%
1/6 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
3.0%
1/33 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
5.9%
10/169 • Number of events 10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
5.9%
2/34 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Palatal swelling
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
16.7%
1/6 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
20.0%
1/5 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
9.1%
3/33 • Number of events 3 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
11.8%
20/169 • Number of events 22 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
5.9%
2/34 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Psychiatric disorders
Agitation
|
11.1%
1/9 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
1.8%
3/169 • Number of events 3 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.59%
1/169 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
5.9%
2/34 • Number of events 3 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Cystitis
|
11.1%
1/9 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Infections and infestations
Postoperative wound infection
|
11.1%
1/9 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
10.0%
1/10 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
25.0%
1/4 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
16.7%
1/6 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
6.1%
2/33 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
3.0%
5/169 • Number of events 5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
2.9%
1/34 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Incision site swelling
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
10.0%
1/10 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
10.0%
1/10 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
25.0%
1/4 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
9.1%
3/33 • Number of events 3 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
5.3%
9/169 • Number of events 9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
44.4%
4/9 • Number of events 4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
60.0%
3/5 • Number of events 3 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
25.0%
1/4 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
70.0%
7/10 • Number of events 7 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
50.0%
3/6 • Number of events 3 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
50.0%
3/6 • Number of events 3 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
66.7%
22/33 • Number of events 22 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
58.0%
98/169 • Number of events 109 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
70.6%
24/34 • Number of events 25 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
20.0%
1/5 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
25.0%
1/4 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
10.0%
1/10 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
6.1%
2/33 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
2.4%
4/169 • Number of events 4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
2.9%
1/34 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Investigations
Body temperature increased
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.59%
1/169 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
5.9%
2/34 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
16.7%
1/6 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
16.7%
1/6 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
5.9%
2/34 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
16.7%
1/6 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
2.9%
1/34 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
3.0%
1/33 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
1.2%
2/169 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
2.9%
1/34 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Renal and urinary disorders
Haematuria
|
22.2%
2/9 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
1.2%
2/169 • Number of events 2 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/9 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/5 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/4 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/10 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/6 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
16.7%
1/6 • Number of events 1 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/33 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/169 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
0.00%
0/34 • Up to 14 days
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. All participants who received ≥1 dose of study drug are included.
|
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 The sponsor will comply with the requirements for publication of study results. 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.
- Publication restrictions are in place
Restriction type: OTHER