Trial Outcomes & Findings for Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038) (NCT NCT01422304)
NCT ID: NCT01422304
Last Updated: 2021-02-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1198 participants
Primary outcome timeframe
Up to 24 hours post study drug administration
Results posted on
2021-02-12
Participant Flow
Participant milestones
| Measure |
Sugammadex
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.
|
Usual Care
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 Study
STARTED
|
598
|
600
|
|
Overall Study
Treated
|
595
|
589
|
|
Overall Study
COMPLETED
|
574
|
563
|
|
Overall Study
NOT COMPLETED
|
24
|
37
|
Reasons for withdrawal
| Measure |
Sugammadex
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.
|
Usual Care
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 Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
14
|
20
|
|
Overall Study
Never Entered Follow-up
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Did Not Meet Protocol Eligibility
|
0
|
2
|
|
Overall Study
Not Treated
|
3
|
11
|
Baseline Characteristics
Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
Baseline characteristics by cohort
| Measure |
Sugammadex
n=596 Participants
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.
|
Usual Care
n=588 Participants
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
n=1184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
66.6 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
66.7 years
STANDARD_DEVIATION 11.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
326 Participants
n=93 Participants
|
340 Participants
n=4 Participants
|
666 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
270 Participants
n=93 Participants
|
248 Participants
n=4 Participants
|
518 Participants
n=27 Participants
|
|
Activated Partial Thromboplastin Time (aPTT)
|
31.14 seconds
STANDARD_DEVIATION 4.38 • n=93 Participants
|
31.01 seconds
STANDARD_DEVIATION 4.14 • n=4 Participants
|
31.08 seconds
STANDARD_DEVIATION 4.26 • n=27 Participants
|
|
Prothrombin Time (International Normalized Ratio) (PT[INR])
|
1.121 ratio
STANDARD_DEVIATION 0.159 • n=93 Participants
|
1.114 ratio
STANDARD_DEVIATION 0.132 • n=4 Participants
|
1.117 ratio
STANDARD_DEVIATION 0.147 • n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours post study drug administrationPopulation: APaT population
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.
Outcome measures
| Measure |
Sugammadex
n=596 Participants
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.
|
Usual Care
n=588 Participants
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).
|
|---|---|---|
|
Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration
|
17 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Baseline, 10 and 60 minutes post study drug administrationPopulation: 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).
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.
Outcome measures
| Measure |
Sugammadex
n=556 Participants
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.
|
Usual Care
n=535 Participants
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).
|
|---|---|---|
|
Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at 10 and 60 Minutes Post Study Drug Administration
10 minutes (Sugammadex n=525, Usual Care n=507)
|
6.0 percent change
Standard Deviation 22.4 • Interval 3.4 to 5.9
|
-0.1 percent change
Standard Deviation 13.6 • Interval -2.0 to 0.4
|
|
Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at 10 and 60 Minutes Post Study Drug Administration
60 minutes (Sugammadex n=523, Usual Care n=505)
|
0.4 percent change
Standard Deviation 29.1
|
-1.2 percent change
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: Baseline, 10 and 60 minutes post study drug administrationPopulation: 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).
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.
Outcome measures
| Measure |
Sugammadex
n=557 Participants
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.
|
Usual Care
n=535 Participants
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).
|
|---|---|---|
|
Percent Change From Baseline in Prothrombin Time (International Normalized Ratio) (PT[INR]) at 10 and 60 Minutes Post Study Drug Administration
10 minutes (Sugammadex n=526, Usual Care n=507)
|
8.0 percent change
Standard Deviation 63.4
|
2.5 percent change
Standard Deviation 14.3
|
|
Percent Change From Baseline in Prothrombin Time (International Normalized Ratio) (PT[INR]) at 10 and 60 Minutes Post Study Drug Administration
60 minutes (Sugammadex n=524, Usual Care n=505)
|
8.9 percent change
Standard Deviation 79.8
|
3.4 percent change
Standard Deviation 23.2
|
SECONDARY outcome
Timeframe: Up to 14 days post study drug administrationPopulation: APaT population
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.
Outcome measures
| Measure |
Sugammadex
n=596 Participants
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.
|
Usual Care
n=588 Participants
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).
|
|---|---|---|
|
Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 14 Days After Study Drug Administration
|
24 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Up to 24 hours post study drug administrationPopulation: APaT population
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.
Outcome measures
| Measure |
Sugammadex
n=596 Participants
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.
|
Usual Care
n=588 Participants
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).
|
|---|---|---|
|
Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 24 Hours After Study Drug Administration
|
12 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Up to 14 days post study drug administrationPopulation: APaT population
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.
Outcome measures
| Measure |
Sugammadex
n=596 Participants
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.
|
Usual Care
n=588 Participants
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).
|
|---|---|---|
|
Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 14 Days After Study Drug Administration
|
18 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Up to 14 days post study drug administrationPopulation: APaT population
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).
Outcome measures
| Measure |
Sugammadex
n=596 Participants
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.
|
Usual Care
n=588 Participants
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).
|
|---|---|---|
|
Number of Participants With One or More Adjudicated Venous Thromboembolic (VTE) Events With Onset Within 14 Days After Study Drug Administration
|
5 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Up to 14 days post study drug administrationPopulation: APaT population
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.
Outcome measures
| Measure |
Sugammadex
n=596 Participants
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.
|
Usual Care
n=588 Participants
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).
|
|---|---|---|
|
Number of Participants With One or More Adjudicated Events of Anaphylaxis With Onset Within 14 Days After Study Drug Administration
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 hours post study drug administrationPopulation: APaT population
The total volume of postoperative drainage from the surgical site over the 24 hours after study drug administration was recorded.
Outcome measures
| Measure |
Sugammadex
n=596 Participants
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.
|
Usual Care
n=588 Participants
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).
|
|---|---|---|
|
Postoperative Drainage Volume Within 24 Hours After Study Drug Administration
|
464 mL
Standard Deviation 367.5
|
476 mL
Standard Deviation 375.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From end of study drug administration through approximately 120 hours after study drug administrationPopulation: APaT population
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.
Outcome measures
| Measure |
Sugammadex
n=596 Participants
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.
|
Usual Care
n=588 Participants
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).
|
|---|---|---|
|
Number of Participants Requiring Any Postoperative Transfusion
|
221 participants
|
227 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From end of study drug administration through approximately 120 hours after study drug administrationPopulation: 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)
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.
Outcome measures
| Measure |
Sugammadex
n=221 Participants
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.
|
Usual Care
n=227 Participants
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 Transfusion Volume in Participants Who Required Postoperative Transfusion
|
335 mL
Geometric Coefficient of Variation 74
|
345 mL
Geometric Coefficient of Variation 84.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Visit 3 (24-48 hours post study drug administration)Population: APaT population
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.
Outcome measures
| Measure |
Sugammadex
n=596 Participants
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.
|
Usual Care
n=588 Participants
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).
|
|---|---|---|
|
Postoperative Changes in Hgb Concentrations Using the Bleeding Index
|
-15.7 g/L
Standard Deviation 15.7
|
-17.4 g/L
Standard Deviation 17.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 72 hours post study drug administrationPopulation: APaT population
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.
Outcome measures
| Measure |
Sugammadex
n=596 Participants
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.
|
Usual Care
n=588 Participants
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).
|
|---|---|---|
|
Number of Participants With One or More Postoperative Anemia Adverse Events With Onset Within 72 Hours After Study Drug Administration
|
124 participants
|
132 participants
|
Adverse Events
Sugammadex
Serious events: 39 serious events
Other events: 491 other events
Deaths: 0 deaths
Usual Care
Serious events: 40 serious events
Other events: 499 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sugammadex
n=596 participants at risk
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.
|
Usual Care
n=588 participants at risk
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).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Cardiac disorders
Acute myocardial infarction
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Cardiac disorders
Mitral valve stenosis
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Gastrointestinal disorders
Tooth loss
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
General disorders
Asthenia
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
General disorders
Device breakage
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
General disorders
Device dislocation
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
General disorders
Drug withdrawal syndrome
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
General disorders
Impaired healing
|
0.34%
2/596 • Number of events 2 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.68%
4/588 • Number of events 4 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
General disorders
Pain
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Infections and infestations
Clostridial infection
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Infections and infestations
Nasopharyngitis
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Infections and infestations
Pneumonia
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.34%
2/588 • Number of events 2 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Infections and infestations
Post procedural infection
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Infections and infestations
Rotavirus infection
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Infections and infestations
Sepsis
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Infections and infestations
Urinary tract infection
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Infections and infestations
Wound infection staphylococcal
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.34%
2/588 • Number of events 2 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Femoral nerve injury
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.34%
2/588 • Number of events 2 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Seroma
|
0.34%
2/596 • Number of events 2 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.34%
2/596 • Number of events 2 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.34%
2/596 • Number of events 2 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.68%
4/588 • Number of events 4 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Investigations
C-reactive protein increased
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.0%
6/596 • Number of events 6 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Nervous system disorders
Peripheral nerve lesion
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Nervous system disorders
Transient ischaemic attack
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 2 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Renal and urinary disorders
Renal failure
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/596 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.17%
1/588 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Surgical and medical procedures
Supportive care
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.51%
3/588 • Number of events 3 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Vascular disorders
Deep vein thrombosis
|
0.17%
1/596 • Number of events 1 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.00%
0/588 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Vascular disorders
Haematoma
|
0.50%
3/596 • Number of events 3 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
0.34%
2/588 • Number of events 2 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
Other adverse events
| Measure |
Sugammadex
n=596 participants at risk
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.
|
Usual Care
n=588 participants at risk
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).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.1%
72/596 • Number of events 75 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
12.6%
74/588 • Number of events 74 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Gastrointestinal disorders
Constipation
|
21.5%
128/596 • Number of events 129 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
24.8%
146/588 • Number of events 148 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Gastrointestinal disorders
Nausea
|
20.8%
124/596 • Number of events 138 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
23.6%
139/588 • Number of events 154 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
64/596 • Number of events 67 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
11.9%
70/588 • Number of events 74 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
General disorders
Oedema peripheral
|
8.9%
53/596 • Number of events 55 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
8.0%
47/588 • Number of events 50 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
General disorders
Pain
|
15.3%
91/596 • Number of events 112 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
17.2%
101/588 • Number of events 124 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
10.6%
63/596 • Number of events 64 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
11.1%
65/588 • Number of events 66 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Injury, poisoning and procedural complications
Procedural pain
|
34.1%
203/596 • Number of events 224 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
39.8%
234/588 • Number of events 259 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.5%
33/596 • Number of events 33 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
7.7%
45/588 • Number of events 47 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
54/596 • Number of events 84 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
6.8%
40/588 • Number of events 60 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Psychiatric disorders
Insomnia
|
8.4%
50/596 • Number of events 50 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
9.2%
54/588 • Number of events 55 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Psychiatric disorders
Sleep disorder
|
14.6%
87/596 • Number of events 90 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
14.3%
84/588 • Number of events 86 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.4%
26/596 • Number of events 31 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
5.4%
32/588 • Number of events 38 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Vascular disorders
Haematoma
|
9.9%
59/596 • Number of events 61 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
9.0%
53/588 • Number of events 54 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
|
Vascular disorders
Hypotension
|
4.5%
27/596 • Number of events 28 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
6.3%
37/588 • Number of events 40 • Up to 14 days post study drug administration
Adverse event tables include participants in APaT population
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER