A Phase 4 interventional study of Sugammadex 2 mg/kg ABW and Sugammadex 2 mg/kg IBW in Neuromuscular Blockade, sponsored by Merck Sharp & Dohme LLC. Completed at 24 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-28.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 4, Interventional, and Treatment
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The purpose of this trial is to evaluate the safety and efficacy of Sugammadex when administered according to actual body weight (ABW) as compared to ideal body weight (IBW) for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either Rocuronium or Vecuronium in morbidly obese participants. The primary hypothesis of this investigation is that, compared to obese participants dosed based on IBW, obese participants receiving Sugammadex according to ABW will demonstrate a faster time to recovery to a Train Of Four (TOF) ratio of ≥0.9 (i.e. faster NMB reversal), pooled across NMB depth and type of neuromuscular blocking agent (NMBA; Rocuronium or Vecuronium) administered.
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following administration of NMBA, participants received a single intravenous (i.v.) bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.
Drug: Sugammadex 2 mg/kg ABW · Drug: Rocuronium or Vecuronium
Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB.
Drug: Sugammadex 2 mg/kg IBW · Drug: Rocuronium or Vecuronium
Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.
Drug: Sugammadex 4 mg/kg ABW · Drug: Rocuronium or Vecuronium
Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB.
Drug: Sugammadex 4 mg/kg IBW · Drug: Rocuronium or Vecuronium
Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.
Drug: Neostigmine + Glycopyrrolate · Drug: Rocuronium or Vecuronium
Drug page: Sugammadex
Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by ABW) for reversal of moderate NMB. Moderate NMB is defined as the reappearance of a second twitch (T2) in response to TOF stimulations.
Also known as: MK-8616
Drug page: Sugammadex
Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by IBW) for reversal of moderate NMB. Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations.
Also known as: MK-8616
Drug page: Sugammadex
Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex (4 mg/kg by ABW) for reversal of deep NMB. Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs).
Also known as: MK-8616
Drug page: Sugammadex
Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants will receive a single i.v. bolus of Sugammadex (4 mg/kg by IBW) for reversal of deep NMB. Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs).
Also known as: MK-8616
Drug pages: Neostigmine · Glycopyrrolate
Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Neostigmine (50 µg/kg; 5 mg maximum) and Glycopyrrolate (10 µg/kg; 1 mg maximum), dosed according to participant ABW for reversal of moderate NMB. Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations.
To achieve NMB, participants received steroidal NMBA Rocuronium Bromide or Vecuronium Bromide administered via i.v. infusion and dosed according to participant ABW. NMBAs were concomitant medications used per label as adjunct to general anesthesia.
Time to Recovery (TTR) of Participant Train Of Four (TOF) Ratio to ≥0.9: Primary Kaplan-Meier Analysis
The primary efficacy analysis of TTR of TOF ratio to ≥0.9 was performed by estimating event rates within each treatment group using the Kaplan-Meier method. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Time frame: Up to 76 minutes
Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events
The percentage of participants experiencing treatment-emergent bradycardia events were identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia is defined as a heart rate \<60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not be considered an adverse event (AE), as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Time frame: Up to 35 minutes
Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events
The percentage of participants experiencing treatment-emergent sinus tachycardia events were identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Time frame: Up to 35 minutes
Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events
The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events were identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias are defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachyarrhythmia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Time frame: Up to 35 minutes
Percentage of Participants Experiencing an Adverse Event (AE) After Administration of Study Intervention
The percentage of participants experiencing an AE following administration of study intervention was monitored. An AE is 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. Further, any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment is also considered an AE. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Time frame: Up to 7 days
Percentage of Participants Experiencing a Serious Adverse Event (SAE) After Administration of Study Intervention
The percentage of participants experiencing an SAE following administration of study intervention was monitored. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially requiring medical or surgical intervention. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Time frame: Up to 7 days
Percentage of Participants Experiencing an Event of Clinical Interest (ECI) After Administration of Study Intervention
The percentage of participants experiencing an ECI following administration of study intervention was monitored. ECIs are a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Time frame: Up to 7 days
Percentage of Participants With Prolonged (>10 Minutes) Time to Recovery (TTR) of the Train Of Four (TOF) Ratio to ≥0.9
Following administration of study intervention, the percentage of participants experiencing prolonged (\>10 minutes) recovery to a TOF ratio ≥0.9 was calculated. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Time frame: Up to 76 minutes
Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.9: Secondary Geometric Mean Analysis
The secondary efficacy analysis of TTR of participant TOF ratio to ≥0.9 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Time frame: Up to 76 minutes
Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.8: Geometric Mean Analysis
The efficacy analysis of TTR of participant TOF ratio to ≥0.8 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.8 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Time frame: Up to 69 minutes
Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.7: Geometric Mean Analysis
The efficacy analysis of TTR of participant TOF ratio to ≥0.7 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.7 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
Time frame: Up to 61 minutes
| Milestone | Sugammadex 2 mg/kg Actual Body Weight (ABW) | Sugammadex 4 mg/kg ABW | Sugammadex 2 mg/kg Ideal Body Weight (IBW) | Sugammadex 4 mg/kg IBW | Neostigmine/Glycopyrrolate |
|---|---|---|---|---|---|
| Started | 41 | 41 | 41 | 42 | 42 |
| Treated | 38 | 38 | 38 | 36 | 38 |
| Completed | 38 | 37 | 37 | 36 | 37 |
| Not completed | 3 | 4 | 4 | 6 | 5 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 2 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 1 | 0 |
| Withdrew: Study medication not received as planned | 2 | 3 | 2 | 3 | 2 |
| Withdrew: Screen failure | 0 | 0 | 0 | 1 | 1 |
The primary efficacy analysis of TTR of TOF ratio to ≥0.9 was performed by estimating event rates within each treatment group using the Kaplan-Meier method. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
| Minutes | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Neostigmine/Glycopyrrolate |
|---|---|---|---|---|---|---|---|
| Time to Recovery (TTR) of Participant Train Of Four (TOF) Ratio to ≥0.9: Primary Kaplan-Meier Analysis | 1.7 (1.5 to 2.1) | 1.8 (1.5 to 2.1) | 1.8 (1.6 to 2.1) | 3.4 (2.2 to 4.4) | 3.3 (2.4 to 4.2) | 3.3 (2.6 to 4.1) | 34.5 (27.0 to 67.4) |
The percentage of participants experiencing treatment-emergent bradycardia events were identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia is defined as a heart rate \<60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not be considered an adverse event (AE), as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
| Percentage of participants | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Neostigmine/Glycopyrrolate |
|---|---|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events | 5.3 | 5.3 | 5.3 | 2.6 | 5.6 | 4.1 | 2.6 |
The percentage of participants experiencing treatment-emergent sinus tachycardia events were identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
| Percentage of participants | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Neostigmine/Glycopyrrolate |
|---|---|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events | 10.5 | 13.2 | 11.8 | 7.9 | 2.8 | 5.4 | 7.9 |
The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events were identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias are defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachyarrhythmia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
| Percentage of participants | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Neostigmine/Glycopyrrolate |
|---|---|---|---|---|---|---|---|
| Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events | 0.0 | 0.0 | 0.0 | 2.6 | 0.0 | 1.4 | 2.6 |
The percentage of participants experiencing an AE following administration of study intervention was monitored. An AE is 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. Further, any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment is also considered an AE. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
| Percentage of participants | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Neostigmine/Glycopyrrolate |
|---|---|---|---|---|---|---|---|
| Percentage of Participants Experiencing an Adverse Event (AE) After Administration of Study Intervention | 94.7 | 86.8 | 90.8 | 94.7 | 91.7 | 93.2 | 89.5 |
The percentage of participants experiencing an SAE following administration of study intervention was monitored. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially requiring medical or surgical intervention. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
| Percentage of participants | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Neostigmine/Glycopyrrolate |
|---|---|---|---|---|---|---|---|
| Percentage of Participants Experiencing a Serious Adverse Event (SAE) After Administration of Study Intervention | 2.6 | 0.0 | 1.3 | 5.3 | 8.3 | 6.8 | 7.9 |
The percentage of participants experiencing an ECI following administration of study intervention was monitored. ECIs are a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
| Percentage of participants | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Neostigmine/Glycopyrrolate |
|---|---|---|---|---|---|---|---|
| Percentage of Participants Experiencing an Event of Clinical Interest (ECI) After Administration of Study Intervention | 0.0 | 2.6 | 1.3 | 2.6 | 2.8 | 2.7 | 2.6 |
Following administration of study intervention, the percentage of participants experiencing prolonged (\>10 minutes) recovery to a TOF ratio ≥0.9 was calculated. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
| Percentage of participants | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Neostigmine/Glycopyrrolate |
|---|---|---|---|---|---|---|---|
| Percentage of Participants With Prolonged (>10 Minutes) Time to Recovery (TTR) of the Train Of Four (TOF) Ratio to ≥0.9 | 7.9 | 2.7 | 5.3 | 5.4 | 0.0 | 2.7 | 84.2 |
The secondary efficacy analysis of TTR of participant TOF ratio to ≥0.9 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
| Minutes | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Neostigmine/Glycopyrrolate |
|---|---|---|---|---|---|---|---|
| Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.9: Secondary Geometric Mean Analysis | 2.0 (1.7 to 2.5) | 1.9 (1.5 to 2.3) | 2.0 (1.7 to 2.3) | 3.2 (2.6 to 3.9) | 3.5 (2.9 to 4.3) | 3.3 (2.9 to 3.8) | 23.1 (18.3 to 29.2) |
The efficacy analysis of TTR of participant TOF ratio to ≥0.8 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.8 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
| Minutes | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Neostigmine/Glycopyrrolate |
|---|---|---|---|---|---|---|---|
| Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.8: Geometric Mean Analysis | 1.6 (1.3 to 1.8) | 1.5 (1.2 to 1.7) | 1.5 (1.3 to 1.7) | 2.5 (2.1 to 2.9) | 2.6 (2.1 to 3.1) | 2.5 (2.2 to 2.8) | 16.6 (12.8 to 21.7) |
The efficacy analysis of TTR of participant TOF ratio to ≥0.7 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.7 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW \[2 mg/kg ABW plus 4 mg/kg ABW\] and Sugammadex IBW \[2 mg/kg IBW plus 4 mg/kg IBW\]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).
| Minutes | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Neostigmine/Glycopyrrolate |
|---|---|---|---|---|---|---|---|
| Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.7: Geometric Mean Analysis | 1.4 (1.2 to 1.6) | 1.3 (1.2 to 1.6) | 1.4 (1.2 to 1.5) | 2.1 (1.8 to 2.4) | 2.0 (1.7 to 2.5) | 2.1 (1.8 to 2.3) | 10.9 (8.1 to 14.6) |
Collected over Up to 14 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sugammadex 2 mg/kg ABW | 0/38 (0%) | 1/38 (2.6%) | 36/38 (94.7%) |
| Sugammadex 4 mg/kg ABW | 0/38 (0%) | 0/38 (0%) | 32/38 (84.2%) |
| Sugammadex 2 mg/kg IBW | 0/38 (0%) | 3/38 (7.9%) | 36/38 (94.7%) |
| Sugammadex 4 mg/kg IBW | 0/36 (0%) | 4/36 (11.1%) | 32/36 (88.9%) |
| Neostigmine + Glycopyrrolate | 1/38 (2.6%) | 3/38 (7.9%) | 32/38 (84.2%) |
| Event | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Neostigmine + Glycopyrrolate |
|---|---|---|---|---|---|
| Impaired healingGeneral disorders | 0/38 | 0/38 | 0/38 | 1/36 | 0/38 |
| PneumoniaInfections and infestations | 0/38 | 0/38 | 1/38 | 1/36 | 0/38 |
| Postoperative wound complicationInjury, poisoning and procedural complications | 0/38 | 0/38 | 0/38 | 1/36 | 0/38 |
| Borderline ovarian tumourNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/38 | 0/38 | 0/38 | 1/36 | 0/38 |
| Cardiovascular insufficiencyCardiac disorders | 0/38 | 0/38 | 0/38 | 0/36 | 1/38 |
| Myocardial infarctionCardiac disorders | 0/38 | 0/38 | 0/38 | 0/36 | 1/38 |
| TachyarrhythmiaCardiac disorders | 0/38 | 0/38 | 1/38 | 0/36 | 0/38 |
| Abdominal painGastrointestinal disorders | 0/38 | 0/38 | 0/38 | 0/36 | 1/38 |
| Device related infectionInfections and infestations | 0/38 | 0/38 | 1/38 | 0/36 | 0/38 |
| Postoperative wound infectionInfections and infestations | 1/38 | 0/38 | 0/38 | 0/36 | 0/38 |
| Event | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Neostigmine + Glycopyrrolate |
|---|---|---|---|---|---|
| Procedural painInjury, poisoning and procedural complications | 28/38 | 23/38 | 28/38 | 27/36 | 24/38 |
| NauseaGastrointestinal disorders | 6/38 | 9/38 | 10/38 | 6/36 | 7/38 |
| Procedural nauseaInjury, poisoning and procedural complications | 9/38 | 8/38 | 4/38 | 4/36 | 5/38 |
| Incision site painInjury, poisoning and procedural complications | 6/38 | 1/38 | 4/38 | 2/36 | 3/38 |
| ConstipationGastrointestinal disorders | 4/38 | 1/38 | 5/38 | 4/36 | 2/38 |
| HyperglycaemiaMetabolism and nutrition disorders | 2/38 | 2/38 | 5/38 | 1/36 | 2/38 |
| TachycardiaCardiac disorders | 2/38 | 4/38 | 3/38 | 2/36 | 1/38 |
| BradycardiaCardiac disorders | 1/38 | 1/38 | 1/38 | 3/36 | 1/38 |
| Sinus tachycardiaCardiac disorders | 1/38 | 0/38 | 3/38 | 1/36 | 1/38 |
| Short-bowel syndromeGastrointestinal disorders | 1/38 | 1/38 | 3/38 | 0/36 | 1/38 |
| Age, Continuous(Years) | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Neostigmine/Glycopyrrolate | Total |
|---|---|---|---|---|---|---|
| Mean | 47.7 ± 14.4 | 46.4 ± 11.2 | 47.6 ± 14.5 | 49.2 ± 11.7 | 47.7 ± 13.3 | 47.7 ± 13.0 |
| Sex: Female, Male(Participants) | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Neostigmine/Glycopyrrolate | Total |
|---|---|---|---|---|---|---|
| Female | 34 | 24 | 30 | 32 | 29 | 149 |
| Male | 7 | 17 | 11 | 10 | 13 | 58 |
| Ethnicity (NIH/OMB)(Participants) | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Neostigmine/Glycopyrrolate | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 4 | 1 | 5 | 2 | 13 |
| Not Hispanic or Latino | 38 | 37 | 40 | 37 | 39 | 191 |
| Unknown or Not Reported | 2 | 0 | 0 | 0 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Sugammadex 2 mg/kg ABW | Sugammadex 4 mg/kg ABW | Sugammadex 2 mg/kg IBW | Sugammadex 4 mg/kg IBW | Neostigmine/Glycopyrrolate | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 1 | 0 | 1 |
| Black or African American | 2 | 2 | 4 | 3 | 3 | 14 |
| White | 39 | 39 | 37 | 38 | 38 | 191 |
| More than one race | 0 | 0 | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Jan 2018 to primary completion in Jan 2019, 12 months.
Results were first posted in Dec 2019, 10 months after primary completion.
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Studies of the drug tested here: Sugammadex