Trial Outcomes & Findings for Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023) (NCT NCT00298831)

Last Updated: 2019-03-27

Results Overview

Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

224 participants

Primary outcome timeframe

Up to approximately 30 minutes following administration of study treatment

Results posted on

2019-03-27

Participant Flow

The trial was conducted in 19 trial sites in the United States.

Participant milestones

Participant milestones
Measure	Sugammadex Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
Overall Study STARTED	224
Overall Study Treated	197
Overall Study COMPLETED	192
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Sugammadex Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1
Overall Study Participants did not receive treatment	27

Baseline Characteristics

The analysis population was all randomized and treated participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugammadex n=197 Participants Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
Age, Continuous	53 Years STANDARD_DEVIATION 15 • n=5 Participants • The analysis population was all randomized and treated participants.
Sex: Female, Male Female	103 Participants n=5 Participants • The analysis population was all randomized and treated participants.
Sex: Female, Male Male	94 Participants n=5 Participants • The analysis population was all randomized and treated participants.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • The analysis population was all randomized and treated participants.
Race (NIH/OMB) Asian	5 Participants n=5 Participants • The analysis population was all randomized and treated participants.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • The analysis population was all randomized and treated participants.
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants • The analysis population was all randomized and treated participants.
Race (NIH/OMB) White	172 Participants n=5 Participants • The analysis population was all randomized and treated participants.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • The analysis population was all randomized and treated participants.
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants • The analysis population was all randomized and treated participants.

PRIMARY outcome

Timeframe: Up to approximately 30 minutes following administration of study treatment

Population: The analysis population consisted of all treated participants had at least one post baseline T4/T1 ratio to 0.9 efficacy measurement.

Outcome measures

Outcome measures
Measure	Sugammadex n=177 Participants Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9	2.32 Minutes Standard Deviation 2.15

SECONDARY outcome

Timeframe: Up to approximately 10 minutes following administration of study treatment

Population: The analysis population consisted of all treated participants had at least one post baseline T4/T1 ratio to 0.7 efficacy measurement.

Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.7 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.7 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).

Outcome measures

Outcome measures
Measure	Sugammadex n=188 Participants Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.7	1.50 Minutes Standard Deviation 1.07

SECONDARY outcome

Timeframe: Up to approximately 15 minutes following administration of study treatment

Population: The analysis population consisted of all treated participants had at least one post baseline T4/T1 ratio to 0.8 efficacy measurement.

Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.8 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.8 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).

Outcome measures

Outcome measures
Measure	Sugammadex n=188 Participants Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.8	1.80 Minutes Standard Deviation 1.37

SECONDARY outcome

Timeframe: Up to 24 hours

Population: The analysis population consisted of all participants who received investigational product and had at least one post baseline efficacy measurement for the analysis endpoint.

The quality of recovery was assessed by asking the participant 40 questions from a validated Quality of Recovery Questionnaire (QoR-40). Participants were assessed for level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation), if applicable, by asking their name, if they are aware of where they are, and what day it is. Assessment 1 occurred prior to transfer to the recovery room after extubation and Assessment 2 occurred prior to discharge from the recovery room.

Outcome measures

Outcome measures
Measure	Sugammadex n=197 Participants Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
Clinical Assessment of Recovery - Participant's Level of Consciousness Awake and oriented - Assessment 1	138 Participants
Clinical Assessment of Recovery - Participant's Level of Consciousness Awake and oriented - Assessment 2	184 Participants
Clinical Assessment of Recovery - Participant's Level of Consciousness Arousable with minimal stimulation - Assessment 1	51 Participants
Clinical Assessment of Recovery - Participant's Level of Consciousness Arousable with minimal stimulation - Assessment 2	12 Participants
Clinical Assessment of Recovery - Participant's Level of Consciousness Responsive only to tactile stimulation - Assess. 1	8 Participants
Clinical Assessment of Recovery - Participant's Level of Consciousness Responsive only to tactile stimulation - Assess. 2	0 Participants

SECONDARY outcome

Timeframe: Up to 24 hours

Population: The analysis population consisted of all participants who received investigational product and had at least one post baseline efficacy measurement for the analysis endpoint.

5-second head lift test was assessment of the ability of the participant to lift the head for 5 seconds and was performed by a blinded safety assessor. Tests were repeated every 15 minutes until the participant could successfully perform the 5-second head-lift. Assessment 1 occurred prior to transfer to the recovery room after extubation and Assessment 2 occurred prior to discharge from the recovery room.

Outcome measures

Outcome measures
Measure	Sugammadex n=197 Participants Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
Clinical Assessments of Recovery - Participant Able to Perform 5-second Head Lift (5SHL) Able to perform 5SHL during Assessment 1	173 Participants
Clinical Assessments of Recovery - Participant Able to Perform 5-second Head Lift (5SHL) Able to perform 5SHL during Assessment 2	196 Participants

SECONDARY outcome

Timeframe: Up to 24 hours

Population: The analysis population consisted of all participants who received investigational product and had at least one post baseline efficacy measurement for the analysis endpoint.

General muscle weakness check was assessed by the investigator. The assessment of general muscle weakness was based on a scale from 0-10, with 0 representing total paralysis, 1 signifying extreme impairment, 9 for close to no impairment, and 10 for normal muscle strength. Scores of 3, 4, 5, etc. denoted increasing muscle strength in approximately 10% increments. Scores of 9 and lower were denoted as GMW. Assessment 1 occurred prior to transfer to the recovery room after extubation and assessment 2 occurred prior to discharge from the recovery room.

Outcome measures

Outcome measures
Measure	Sugammadex n=197 Participants Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
Clinical Assessments of Recovery - Check for General Muscle Weakness (GMW) GMW present during Assessment 1	4 Participants
Clinical Assessments of Recovery - Check for General Muscle Weakness (GMW) GMW present during Assessment 2	9 Participants

Adverse Events

Sugammadex

Serious events: 8 serious events

Other events: 187 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sugammadex n=197 participants at risk Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
Cardiac disorders Electromechanical dissociation	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Gastrointestinal disorders Ileus	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Gastrointestinal disorders Large intestine perforation	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Gastrointestinal disorders Nausea	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
General disorders Pain	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Infections and infestations Sepsis	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Injury, poisoning and procedural complications Peroneal nerve injury	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Injury, poisoning and procedural complications Procedural complication	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Nervous system disorders Radiculitis brachial	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Psychiatric disorders Delirium	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Psychiatric disorders Psychiatric symptom	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Psychiatric disorders Suicidal ideation	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Renal and urinary disorders Renal failure acute	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Apnoea	0.51% 1/197 • Number of events 1 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.

Other adverse events

Other adverse events
Measure	Sugammadex n=197 participants at risk Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
Blood and lymphatic system disorders Anaemia	5.1% 10/197 • Number of events 10 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Gastrointestinal disorders Constipation	9.6% 19/197 • Number of events 19 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Gastrointestinal disorders Nausea	39.1% 77/197 • Number of events 80 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Gastrointestinal disorders Vomiting	13.2% 26/197 • Number of events 27 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
General disorders Chills	8.1% 16/197 • Number of events 18 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
General disorders Pyrexia	12.7% 25/197 • Number of events 25 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Injury, poisoning and procedural complications Incision site complication	11.7% 23/197 • Number of events 24 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Injury, poisoning and procedural complications Procedural hypertension	6.6% 13/197 • Number of events 15 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Injury, poisoning and procedural complications Procedural hypotension	5.6% 11/197 • Number of events 13 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Injury, poisoning and procedural complications Procedural pain	80.7% 159/197 • Number of events 164 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Investigations Neutrophil count increased	5.1% 10/197 • Number of events 10 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Musculoskeletal and connective tissue disorders Back pain	10.2% 20/197 • Number of events 20 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Nervous system disorders Dizziness	13.7% 27/197 • Number of events 29 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Nervous system disorders Headache	12.7% 25/197 • Number of events 27 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Psychiatric disorders Anxiety	5.1% 10/197 • Number of events 10 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Psychiatric disorders Insomnia	10.2% 20/197 • Number of events 20 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Renal and urinary disorders Bladder spasm	6.1% 12/197 • Number of events 12 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	9.1% 18/197 • Number of events 18 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.
Skin and subcutaneous tissue disorders Pruritus	8.6% 17/197 • Number of events 17 • Up to 7 days after study drug administration An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The population analyzed consisted of all participants who received a dose of the investigational product.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in the protocol will first be submitted to sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
Publication restrictions are in place

Restriction type: OTHER