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Trial record 93 of 186 for:    GLYCOPYRROLATE

Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)

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ClinicalTrials.gov Identifier: NCT01422304
Recruitment Status : Completed
First Posted : August 23, 2011
Results First Posted : October 30, 2013
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Neuromuscular Blockade
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Blood Coagulation
Antithrombotic Agents
Interventions Drug: Sugammadex
Drug: neostigmine and glycopyrrolate or atropine
Drug: Placebo to neostigmine
Drug: Placebo to sugammadex
Enrollment 1198
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg. For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Period Title: Overall Study
Started 598 [1] 600 [1]
Treated 595 589 [2]
Completed 574 563
Not Completed 24 37
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             14             20
Never Entered Follow-up             2             1
Protocol Violation             1             0
Withdrawal by Subject             4             2
Did Not Meet Protocol Eligibility             0             2
Not Treated             3             11
[1]
Randomized
[2]
1 given sugammadex; thus All Participants as Treated (APaT) Ns are 596 Sugammadex, 588 Usual Care
Arm/Group Title Sugammadex Usual Care Total
Hide Arm/Group Description For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg. For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). Total of all reporting groups
Overall Number of Baseline Participants 596 588 1184
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 596 participants 588 participants 1184 participants
66.7  (12.0) 66.6  (11.3) 66.7  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 596 participants 588 participants 1184 participants
Female
326
  54.7%
340
  57.8%
666
  56.3%
Male
270
  45.3%
248
  42.2%
518
  43.8%
Activated Partial Thromboplastin Time (aPTT)   [1] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 596 participants 588 participants 1184 participants
31.14  (4.38) 31.01  (4.14) 31.08  (4.26)
[1]
Measure Description: n=556, 535, 1091 for Sugammadex, Usual Care and Total, respectively
Prothrombin Time (International Normalized Ratio) (PT[INR])   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 596 participants 588 participants 1184 participants
1.121  (0.159) 1.114  (0.132) 1.117  (0.147)
[1]
Measure Description: n=557, 535, 1092 for Sugammadex, Usual Care and Total, respectively
1.Primary Outcome
Title Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration
Hide Description Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a "suspected, unanticipated adverse event of bleeding" (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant (e.g., in amount of blood lost, prolonged duration of bleeding, or other factors) considering the type of procedure as well as participant’s specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding.
Time Frame Up to 24 hours post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
APaT population
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 596 588
Measure Type: Number
Unit of Measure: participants
17 24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments Cochran-Mantel-Haenszel method was stratified for renal function (estimated creatinine clearance < or ≥ 60 mL/min) and prophylactic antithrombotic therapy (including low molecular weight heparin [LMWH], including unfractionated heparin [UFH], or not including either LMWH or UFH)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.38 to 1.29
Estimation Comments Relative risk is Sugammadex versus Usual Care
2.Secondary Outcome
Title Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at 10 and 60 Minutes Post Study Drug Administration
Hide Description Change from baseline in aPTT is identified in study protocol as the Key Secondary Outcome Measure. Blood samples for determination of aPTT values were obtained at baseline and at 10 and 60 minutes after study drug administration. aPTT is a performance indicator measuring the efficacy of the intrinsic and common blood coagulation (blood clotting) pathways. Higher values of aPTT indicate a reduction in the clotting tendency of blood.
Time Frame Baseline, 10 and 60 minutes post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in APaT population who had baseline and at least one post baseline aPTT measurement within defined assessment window (10 or 60 minutes post study drug).
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 556 535
Mean (Standard Deviation)
Unit of Measure: percent change
10 minutes (Sugammadex n=525, Usual Care n=507) 6.0  (22.4) -0.1  (13.6)
60 minutes (Sugammadex n=523, Usual Care n=505) 0.4  (29.1) -1.2  (22.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance < or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)
Method of Estimation Estimation Parameter Geometric Mean Ratio (GMR) (%)
Estimated Value 5.5
Confidence Interval (2-Sided) 95%
3.7 to 7.3
Estimation Comments Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = [GMR – 1]*100).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance < or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)
Method of Estimation Estimation Parameter GMR (%)
Estimated Value 0.9
Confidence Interval 95%
-0.9 to 2.8
Estimation Comments Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = [GMR – 1]*100).
3.Secondary Outcome
Title Percent Change From Baseline in Prothrombin Time (International Normalized Ratio) (PT[INR]) at 10 and 60 Minutes Post Study Drug Administration
Hide Description Change from baseline in PT(INR) is identified in study protocol as an Other Secondary Outcome Measure. Blood samples for determination of PT(INR) values were obtained at baseline and at 10 and 60 minutes after study drug administration. PT(INR) is a performance indicator measuring the efficacy of the extrinsic and common blood coagulation (blood clotting) pathways. The INR is the ratio of a participant's prothrombin time to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the analytical system used (INR = [PT-Test/PT-Normal]^ISI). Higher values of PT(INR) indicate a reduction in the clotting tendency of blood.
Time Frame Baseline, 10 and 60 minutes post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in APaT population who had baseline and at least one post baseline PT(INR) measurement within defined assessment window (10 or 60 minutes post study drug).
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 557 535
Mean (Standard Deviation)
Unit of Measure: percent change
10 minutes (Sugammadex n=526, Usual Care n=507) 8.0  (63.4) 2.5  (14.3)
60 minutes (Sugammadex n=524, Usual Care n=505) 8.9  (79.8) 3.4  (23.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance < or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)
Method of Estimation Estimation Parameter GMR (%)
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
1.3 to 4.7
Estimation Comments Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = [GMR – 1]*100).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance < or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)
Method of Estimation Estimation Parameter GMR (%)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-1.0 to 2.9
Estimation Comments Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = [GMR – 1]*100).
4.Secondary Outcome
Title Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 14 Days After Study Drug Administration
Hide Description This Measure is identified in study protocol as an Other Secondary Outcome Measure. Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a "suspected, unanticipated adverse event of bleeding" (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant considering the type of procedure as well as participant’s specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding.
Time Frame Up to 14 days post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
APaT population
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 596 588
Measure Type: Number
Unit of Measure: participants
24 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (%)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-3.0 to 1.8
Estimation Comments Risk difference (%) = Sugammadex incidence - Usual Care incidence
5.Secondary Outcome
Title Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 24 Hours After Study Drug Administration
Hide Description This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. Major bleeding event (MBE) = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in hemoglobin (Hgb) level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red blood cells (RBCs), occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.
Time Frame Up to 24 hours post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
APaT population
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 596 588
Measure Type: Number
Unit of Measure: participants
12 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (%)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-3.4 to 0.5
Estimation Comments Risk difference (%) = Sugammadex incidence - Usual Care incidence
6.Secondary Outcome
Title Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 14 Days After Study Drug Administration
Hide Description This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. MBE = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in Hgb level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or RBCs, occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.
Time Frame Up to 14 days post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
APaT population
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 596 588
Measure Type: Number
Unit of Measure: participants
18 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (%)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-3.1 to 1.2
Estimation Comments Risk difference (%) = Sugammadex incidence - Usual Care incidence
7.Secondary Outcome
Title Number of Participants With One or More Adjudicated Venous Thromboembolic (VTE) Events With Onset Within 14 Days After Study Drug Administration
Hide Description This Measure is identified in study protocol as an Other Secondary Outcome Measure. Suspected symptomatic VTE events were evaluated by a blinded external Adjudication Committee. The confirmation of a VTE event was based on determination of a clinically meaningful venous thrombosis (e.g., pulmonary embolism or deep vein thrombosis).
Time Frame Up to 14 days post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
APaT population
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 596 588
Measure Type: Number
Unit of Measure: participants
5 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (%)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.7 to 1.5
Estimation Comments Risk difference (%) = Sugammadex incidence - Usual Care incidence
8.Secondary Outcome
Title Number of Participants With One or More Adjudicated Events of Anaphylaxis With Onset Within 14 Days After Study Drug Administration
Hide Description This Measure is identified in study protocol as an Other Secondary Outcome Measure. Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Adverse events suggestive of hypersensitivity which met defined criteria (e.g., serious event) and/or suspected events of anaphylaxis were evaluated by a blinded external Adjudication Committee to determine whether such events met either of the following two criteria for anaphylaxis (Sampson et al. J Allergy Clin Immunol 2006;117:391-7) - 1. Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of the following: a) respiratory compromise, b) reduced blood pressure (BP) or associated symptoms of end-organ dysfunction. 2. Two or more of the following that occur rapidly after exposure to a likely allergen for that participant: a) involvement of the skin-mucosal tissue, b) respiratory compromise, c) reduced BP or associated symptoms, d) persistent gastrointestinal symptoms.
Time Frame Up to 14 days post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
APaT population
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 596 588
Measure Type: Number
Unit of Measure: participants
0 0
9.Other Pre-specified Outcome
Title Postoperative Drainage Volume Within 24 Hours After Study Drug Administration
Hide Description The total volume of postoperative drainage from the surgical site over the 24 hours after study drug administration was recorded.
Time Frame Up to 24 hours post study drug administration
Hide Outcome Measure Data
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APaT population
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 596 588
Mean (Standard Deviation)
Unit of Measure: mL
464  (367.5) 476  (375.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Generalized Linear Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.2
Confidence Interval (2-Sided) 95%
-45.0 to 30.5
Estimation Comments Difference is Sugammadex versus Usual Care. A negative value indicates that the average adjusted drainage volume was lower in the sugammadex treatment group.
10.Other Pre-specified Outcome
Title Number of Participants Requiring Any Postoperative Transfusion
Hide Description The number of participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion) was determined.
Time Frame From end of study drug administration through approximately 120 hours after study drug administration
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APaT population
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 596 588
Measure Type: Number
Unit of Measure: participants
221 227
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments Miettinen and Nurminen Method was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (%)
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-7.4 to 2.0
Estimation Comments Risk difference (%) = Sugammadex incidence - Usual Care incidence, adjusted for strata and investigational site
11.Other Pre-specified Outcome
Title Total Transfusion Volume in Participants Who Required Postoperative Transfusion
Hide Description Among participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion), the total volume of blood transfused post study drug was calculated. The volume of blood transfused post study drug (using linear interpolation when transfusions were ongoing at the time of study drug administration) was converted to grams of Hgb transfused, using RBC concentration information received from the investigators. The sum of Hgb transfused was standardized to “normal” volume Hgb in homologous whole blood, using 20 g/dL Hgb for calculation of the standardized volume.
Time Frame From end of study drug administration through approximately 120 hours after study drug administration
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Participants in APaT population who received a transfusion unit that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion)
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 221 227
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL
335
(74%)
345
(84.5%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments Generalized Linear Model was applied to transfusion volume transformed to the log-scale, adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site. Result and 95% Confidence Interval was transformed back to the original scale.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Generalized Linear Model
Comments [Not Specified]
Method of Estimation Estimation Parameter GMR
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.98 to 1.24
Estimation Comments GMR is Sugammadex versus Usual Care
12.Other Pre-specified Outcome
Title Postoperative Changes in Hgb Concentrations Using the Bleeding Index
Hide Description The Bleeding Index was used to describe postoperative changes in Hgb concentrations at Visit 3. Bleeding Index = Hgb level at Visit 3 – Hgb level at baseline, adjusted for the amount of RBCs transfused. Missing baseline Hgb values were imputed using the overall mean Hgb value at baseline.
Time Frame Baseline and Visit 3 (24-48 hours post study drug administration)
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APaT population
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 596 588
Mean (Standard Deviation)
Unit of Measure: g/L
-15.7  (15.7) -17.4  (17.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy), investigational site and baseline hemoglobin value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Generalized Linear Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-0.4 to 3.1
Estimation Comments Difference is Sugammadex versus Usual Care. A positive value indicates that the average adjusted reduction in Hgb at Visit 3 (bleeding index) was lower in the sugammadex treatment group.
13.Other Pre-specified Outcome
Title Number of Participants With One or More Postoperative Anemia Adverse Events With Onset Within 72 Hours After Study Drug Administration
Hide Description This measure is the incidence of postoperative anaemia with an onset within 72 hours after study drug administration. A participant is included in the count for this measure if an adverse event with any of the following event terms occurred in the participant with onset within the defined time frame: postoperative anaemia, anaemia, haemorrhagic anaemia, haemoglobin decreased or haemoglobin S decreased.
Time Frame Up to 72 hours post study drug administration
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APaT population
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description:
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
Overall Number of Participants Analyzed 596 588
Measure Type: Number
Unit of Measure: participants
124 132
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugammadex, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (%)
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-6.3 to 3.1
Estimation Comments Risk difference (%) = Sugammadex incidence - Usual Care incidence
Time Frame Up to 14 days post study drug administration
Adverse Event Reporting Description Adverse event tables include participants in APaT population
 
Arm/Group Title Sugammadex Usual Care
Hide Arm/Group Description For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg. For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
All-Cause Mortality
Sugammadex Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sugammadex Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/596 (6.54%)      40/588 (6.80%)    
Blood and lymphatic system disorders     
Anaemia  1  1/596 (0.17%)  1 1/588 (0.17%)  1
Cardiac disorders     
Acute myocardial infarction  1  1/596 (0.17%)  1 1/588 (0.17%)  1
Mitral valve stenosis  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Myocardial infarction  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Ventricular fibrillation  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Eye disorders     
Vitreous detachment  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Gastrointestinal disorders     
Colitis ischaemic  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Diarrhoea  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Subileus  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Tooth loss  1  1/596 (0.17%)  1 0/588 (0.00%)  0
General disorders     
Asthenia  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Device breakage  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Device dislocation  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Drug withdrawal syndrome  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Impaired healing  1  2/596 (0.34%)  2 4/588 (0.68%)  4
Pain  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Infections and infestations     
Clostridial infection  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Nasopharyngitis  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Pneumonia  1  0/596 (0.00%)  0 2/588 (0.34%)  2
Post procedural infection  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Rotavirus infection  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Sepsis  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Urinary tract infection  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Wound infection staphylococcal  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Injury, poisoning and procedural complications     
Anaemia postoperative  1  0/596 (0.00%)  0 2/588 (0.34%)  2
Femoral nerve injury  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Femur fracture  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Incision site haematoma  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Periprosthetic fracture  1  1/596 (0.17%)  1 2/588 (0.34%)  2
Post procedural haemorrhage  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Postoperative wound complication  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Seroma  1  2/596 (0.34%)  2 1/588 (0.17%)  1
Subcutaneous haematoma  1  2/596 (0.34%)  2 1/588 (0.17%)  1
Tendon rupture  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Wound dehiscence  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Wound haemorrhage  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Wound secretion  1  2/596 (0.34%)  2 4/588 (0.68%)  4
Investigations     
C-reactive protein increased  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Groin pain  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Joint range of motion decreased  1  6/596 (1.01%)  6 1/588 (0.17%)  1
Joint swelling  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Muscle haemorrhage  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Muscular weakness  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Osteonecrosis  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Chronic lymphocytic leukaemia  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Malignant melanoma  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Nervous system disorders     
Nerve compression  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Paraesthesia  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Peripheral nerve lesion  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Reversible ischaemic neurological deficit  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Transient ischaemic attack  1  1/596 (0.17%)  1 1/588 (0.17%)  2
Renal and urinary disorders     
Oliguria  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Renal failure  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Renal failure acute  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Respiratory, thoracic and mediastinal disorders     
Apnoea  1  0/596 (0.00%)  0 1/588 (0.17%)  1
Pulmonary embolism  1  1/596 (0.17%)  1 1/588 (0.17%)  1
Surgical and medical procedures     
Supportive care  1  1/596 (0.17%)  1 3/588 (0.51%)  3
Vascular disorders     
Deep vein thrombosis  1  1/596 (0.17%)  1 0/588 (0.00%)  0
Haematoma  1  3/596 (0.50%)  3 2/588 (0.34%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sugammadex Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   491/596 (82.38%)      499/588 (84.86%)    
Blood and lymphatic system disorders     
Anaemia  1  72/596 (12.08%)  75 74/588 (12.59%)  74
Gastrointestinal disorders     
Constipation  1  128/596 (21.48%)  129 146/588 (24.83%)  148
Nausea  1  124/596 (20.81%)  138 139/588 (23.64%)  154
Vomiting  1  64/596 (10.74%)  67 70/588 (11.90%)  74
General disorders     
Oedema peripheral  1  53/596 (8.89%)  55 47/588 (7.99%)  50
Pain  1  91/596 (15.27%)  112 101/588 (17.18%)  124
Injury, poisoning and procedural complications     
Anaemia postoperative  1  63/596 (10.57%)  64 65/588 (11.05%)  66
Procedural pain  1  203/596 (34.06%)  224 234/588 (39.80%)  259
Metabolism and nutrition disorders     
Hypokalaemia  1  33/596 (5.54%)  33 45/588 (7.65%)  47
Musculoskeletal and connective tissue disorders     
Arthralgia  1  54/596 (9.06%)  84 40/588 (6.80%)  60
Psychiatric disorders     
Insomnia  1  50/596 (8.39%)  50 54/588 (9.18%)  55
Sleep disorder  1  87/596 (14.60%)  90 84/588 (14.29%)  86
Skin and subcutaneous tissue disorders     
Erythema  1  26/596 (4.36%)  31 32/588 (5.44%)  38
Vascular disorders     
Haematoma  1  59/596 (9.90%)  61 53/588 (9.01%)  54
Hypotension  1  27/596 (4.53%)  28 37/588 (6.29%)  40
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Initial public presentation of the Investigator's results will occur only together with the other sites unless permission is obtained from Sponsor. Sponsor must be able to review all proposed results communications regarding study 45 days prior to submission for publication/presentation. In case of disagreement concerning appropriateness of materials, Investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues, prior to submission for publication/presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01422304     History of Changes
Other Study ID Numbers: P07038
2011-001201-27 ( EudraCT Number )
MK-8616-059 ( Other Identifier: Merck protocol number )
First Submitted: August 22, 2011
First Posted: August 23, 2011
Results First Submitted: August 19, 2013
Results First Posted: October 30, 2013
Last Update Posted: May 23, 2017