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Trial record 59 of 186 for:    GLYCOPYRROLATE

Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025)

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ClinicalTrials.gov Identifier: NCT00473694
Recruitment Status : Completed
First Posted : May 15, 2007
Results First Posted : March 7, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Anesthesia, General
Interventions Drug: sugammadex
Drug: neostigmine
Drug: vecuronium
Drug: rocuronium
Drug: glycopyrrolate
Enrollment 182
Recruitment Details The trial was conducted in 8 trial sites in the United States. A total of 182 participants were randomized with 157 participants treated.
Pre-assignment Details  
Arm/Group Title Rocuronium+Sugammadex Rocuronium+Neostigmine Vecuronium+Sugammadex Vecuronium+Neostigmine
Hide Arm/Group Description Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 post-tetanic counts (PTC) and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered. Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate . Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered. Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate .
Period Title: Overall Study
Started 48 41 [1] 51 42
Treated 37 [2] 38 [2] 46 [2] 36 [2]
Completed 37 [3] 37 [3] 46 [3] 35 [3]
Not Completed 11 4 5 7
Reason Not Completed
Adverse Event             0             1             0             0
Participants did not receive treatment             11             3             5             6
Lost to Follow-up             0             0             0             1
[1]
Includes 1 participant randomized to vecuronium+sugammadex but treated with rocuronium+neostigmine
[2]
Number of participants treated was based on actual treatment received.
[3]
Number of participants completed was based on actual treatment received.
Arm/Group Title Rocuronium+Sugammadex Rocuronium+Neostigmine Vecuronium+Sugammadex Vecuronium+Neostigmine Total
Hide Arm/Group Description Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered. Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate. Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered. Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate. Total of all reporting groups
Overall Number of Baseline Participants 48 40 52 42 182
Hide Baseline Analysis Population Description
The analysis population was all randomized participants.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 40 participants 52 participants 42 participants 182 participants
53.6  (14.0) 54.0  (10.8) 49.9  (13.6) 55.2  (13.3) 53.0  (13.1)
[1]
Measure Analysis Population Description: The analysis population was all randomized participants.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 40 participants 52 participants 42 participants 182 participants
Female
26
  54.2%
20
  50.0%
33
  63.5%
21
  50.0%
100
  54.9%
Male
22
  45.8%
20
  50.0%
19
  36.5%
21
  50.0%
82
  45.1%
[1]
Measure Analysis Population Description: The analysis population was all randomized participants.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 40 participants 52 participants 42 participants 182 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
   7.5%
1
   1.9%
3
   7.1%
7
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   6.3%
1
   2.5%
7
  13.5%
2
   4.8%
13
   7.1%
White
43
  89.6%
36
  90.0%
43
  82.7%
37
  88.1%
159
  87.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   4.2%
0
   0.0%
1
   1.9%
0
   0.0%
3
   1.6%
[1]
Measure Analysis Population Description: The analysis population was all randomized participants.
1.Primary Outcome
Title Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Rocuronium
Hide Description Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.9 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
Time Frame Up to approximately 3 hours after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).
Arm/Group Title Rocuronium+Sugammadex Rocuronium+Neostigmine
Hide Arm/Group Description:
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Overall Number of Participants Analyzed 37 37
Mean (Standard Deviation)
Unit of Measure: Minutes
3.28  (2.40) 55.50  (27.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rocuronium+Sugammadex, Rocuronium+Neostigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Treatment Effect
Estimated Value 17.29
Confidence Interval (2-Sided) 95%
13.95 to 21.42
Estimation Comments The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.
2.Primary Outcome
Title Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Vecuronium
Hide Description Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.9 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
Time Frame Up to approximately 6 hours after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).
Arm/Group Title Vecuronium+Sugammadex Vecuronium+Neostigmine
Hide Arm/Group Description:
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Overall Number of Participants Analyzed 47 36
Mean (Standard Deviation)
Unit of Measure: Minutes
8.73  (14.60) 77.80  (56.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vecuronium+Sugammadex, Vecuronium+Neostigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Treatment Effect
Estimated Value 14.86
Confidence Interval (2-Sided) 95%
10.18 to 21.67
Estimation Comments The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.
3.Secondary Outcome
Title Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Rocuronium
Hide Description Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.7. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.7 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
Time Frame Up to approximately 2 hours after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).
Arm/Group Title Rocuronium+Sugammadex Rocuronium+Neostigmine
Hide Arm/Group Description:
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Overall Number of Participants Analyzed 37 37
Mean (Standard Deviation)
Unit of Measure: Minutes
2.27  (1.25) 37.68  (21.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rocuronium+Sugammadex, Rocuronium+Neostigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Treatment Effect
Estimated Value 15.84
Confidence Interval (2-Sided) 95%
12.58 to 19.95
Estimation Comments The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.
4.Secondary Outcome
Title Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Vecuronium
Hide Description Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.7. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.7 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
Time Frame Up to approximately 4 hours after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).
Arm/Group Title Vecuronium+Sugammadex Vecuronium+Neostigmine
Hide Arm/Group Description:
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Overall Number of Participants Analyzed 47 36
Mean (Standard Deviation)
Unit of Measure: Minutes
4.10  (8.78) 56.17  (36.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vecuronium+Sugammadex, Vecuronium+Neostigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Treatment Effect
Estimated Value 18.45
Confidence Interval (2-Sided) 95%
13.98 to 24.35
Estimation Comments The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.
5.Secondary Outcome
Title Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Rocuronium
Hide Description Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.8. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.8 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
Time Frame Up to approximately 3 hours after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).
Arm/Group Title Rocuronium+Sugammadex Rocuronium+Neostigmine
Hide Arm/Group Description:
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Overall Number of Participants Analyzed 37 37
Mean (Standard Deviation)
Unit of Measure: Minutes
2.65  (1.58) 45.82  (24.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rocuronium+Sugammadex, Rocuronium+Neostigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Treatment Effect
Estimated Value 17.04
Confidence Interval (2-Sided) 95%
13.62 to 21.31
Estimation Comments The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.
6.Secondary Outcome
Title Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Vecuronium
Hide Description Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.8. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.8 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.
Time Frame Up to approximately 5 hours after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).
Arm/Group Title Vecuronium+Sugammadex Vecuronium+Neostigmine
Hide Arm/Group Description:
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Overall Number of Participants Analyzed 47 36
Mean (Standard Deviation)
Unit of Measure: Minutes
5.55  (9.87) 67.42  (44.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vecuronium+Sugammadex, Vecuronium+Neostigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Treatment Effect
Estimated Value 17.70
Confidence Interval (2-Sided) 95%
12.85 to 24.38
Estimation Comments The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.
7.Secondary Outcome
Title Number of Participants Awake and Oriented After Anesthesia (Clinical Assessment of Level of Consciousness)
Hide Description The number of participants who were awake and oriented was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).
Arm/Group Title Rocuronium+Sugammadex Rocuronium+Neostigmine Vecuronium+Sugammadex Vecuronium+Neostigmine
Hide Arm/Group Description:
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Overall Number of Participants Analyzed 37 37 47 36
Measure Type: Count of Participants
Unit of Measure: Participants
Prior to transfer to recovery room
26
  70.3%
20
  54.1%
27
  57.4%
20
  55.6%
Prior to discharge from recovery room
34
  91.9%
32
  86.5%
39
  83.0%
33
  91.7%
8.Secondary Outcome
Title Number of Participants Aroused With Minimal Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)
Hide Description The number of participants aroused with minimal stimulation was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).
Arm/Group Title Rocuronium+Sugammadex Rocuronium+Neostigmine Vecuronium+Sugammadex Vecuronium+Neostigmine
Hide Arm/Group Description:
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Overall Number of Participants Analyzed 37 37 47 36
Measure Type: Count of Participants
Unit of Measure: Participants
Prior to transfer to recovery room
9
  24.3%
11
  29.7%
12
  25.5%
8
  22.2%
Prior to discharge from recovery room
0
   0.0%
1
   2.7%
2
   4.3%
1
   2.8%
9.Secondary Outcome
Title Number of Participants Responsive Only to Tactile Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)
Hide Description The number of participants responsive only to tactile stimulation was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).
Arm/Group Title Rocuronium+Sugammadex Rocuronium+Neostigmine Vecuronium+Sugammadex Vecuronium+Neostigmine
Hide Arm/Group Description:
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate .
Overall Number of Participants Analyzed 37 37 47 36
Measure Type: Count of Participants
Unit of Measure: Participants
Prior to transfer to recovery room
2
   5.4%
3
   8.1%
7
  14.9%
7
  19.4%
Prior to discharge from recovery room
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Participants Able to Perform a 5-second Head Lift
Hide Description The number of participants who were able to lift their head for 5 seconds was assessed by the investigator as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessment was performed every 15 minutes until the first successful 5-second head lift was achieved. Participants who were not cooperative with the examination were not included in the assessment.
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).
Arm/Group Title Rocuronium+Sugammadex Rocuronium+Neostigmine Vecuronium+Sugammadex Vecuronium+Neostigmine
Hide Arm/Group Description:
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Overall Number of Participants Analyzed 37 37 47 36
Measure Type: Count of Participants
Unit of Measure: Participants
Prior to transfer to recovery room
33
  89.2%
28
  75.7%
36
  76.6%
24
  66.7%
Prior to discharge from recovery room
34
  91.9%
33
  89.2%
41
  87.2%
33
  91.7%
11.Secondary Outcome
Title Number of Participants Experiencing General Muscle Weakness
Hide Description The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessments were performed every 15 minutes until the absence of general muscle weakness. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups. Participants who were not cooperative with the examination were not included in the assessment.
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).
Arm/Group Title Rocuronium+Sugammadex Rocuronium+Neostigmine Vecuronium+Sugammadex Vecuronium+Neostigmine
Hide Arm/Group Description:
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.
Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
Overall Number of Participants Analyzed 37 37 47 36
Measure Type: Count of Participants
Unit of Measure: Participants
Prior to transfer to recovery room
3
   8.1%
5
  13.5%
4
   8.5%
2
   5.6%
Prior to discharge from recovery room
2
   5.4%
3
   8.1%
1
   2.1%
3
   8.3%
Time Frame Up to 7 days after administration of study drug
Adverse Event Reporting Description The analysis population consisted of all randomized participants who received at least one dose of the study drug (All Subjects Treated Group).
 
Arm/Group Title Rocuronium+Sugammadex Rocuronium+Neostigmine Vecuronium+Sugammadex Vecuronium+Neostigmine
Hide Arm/Group Description Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered. Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate. Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered. Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.
All-Cause Mortality
Rocuronium+Sugammadex Rocuronium+Neostigmine Vecuronium+Sugammadex Vecuronium+Neostigmine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)      0/38 (0.00%)      0/46 (0.00%)      0/36 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Rocuronium+Sugammadex Rocuronium+Neostigmine Vecuronium+Sugammadex Vecuronium+Neostigmine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/37 (5.41%)      3/38 (7.89%)      2/46 (4.35%)      0/36 (0.00%)    
Gastrointestinal disorders         
Gastric perforation  1  0/37 (0.00%)  0 1/38 (2.63%)  1 0/46 (0.00%)  0 0/36 (0.00%)  0
Nausea  1  0/37 (0.00%)  0 1/38 (2.63%)  1 0/46 (0.00%)  0 0/36 (0.00%)  0
General disorders         
Pain  1  0/37 (0.00%)  0 1/38 (2.63%)  1 0/46 (0.00%)  0 0/36 (0.00%)  0
Infections and infestations         
Postoperative infection  1  1/37 (2.70%)  1 0/38 (0.00%)  0 0/46 (0.00%)  0 0/36 (0.00%)  0
Splenic abscess  1  0/37 (0.00%)  0 0/38 (0.00%)  0 1/46 (2.17%)  1 0/36 (0.00%)  0
Injury, poisoning and procedural complications         
Postoperative ileus  1  1/37 (2.70%)  1 1/38 (2.63%)  1 0/46 (0.00%)  0 0/36 (0.00%)  0
Procedural complication  1  0/37 (0.00%)  0 1/38 (2.63%)  1 0/46 (0.00%)  0 0/36 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Atelectasis  1  0/37 (0.00%)  0 0/38 (0.00%)  0 1/46 (2.17%)  1 0/36 (0.00%)  0
Dyspnoea  1  0/37 (0.00%)  0 1/38 (2.63%)  1 0/46 (0.00%)  0 0/36 (0.00%)  0
1
Term from vocabulary, MedDRA 9.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rocuronium+Sugammadex Rocuronium+Neostigmine Vecuronium+Sugammadex Vecuronium+Neostigmine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/37 (97.30%)      37/38 (97.37%)      46/46 (100.00%)      33/36 (91.67%)    
Blood and lymphatic system disorders         
Anaemia  1  1/37 (2.70%)  1 3/38 (7.89%)  3 0/46 (0.00%)  0 1/36 (2.78%)  1
Leukocytosis  1  1/37 (2.70%)  1 1/38 (2.63%)  1 1/46 (2.17%)  1 2/36 (5.56%)  2
Gastrointestinal disorders         
Abdominal pain  1  1/37 (2.70%)  1 3/38 (7.89%)  3 3/46 (6.52%)  4 1/36 (2.78%)  1
Abdominal tenderness  1  0/37 (0.00%)  0 2/38 (5.26%)  2 0/46 (0.00%)  0 0/36 (0.00%)  0
Constipation  1  2/37 (5.41%)  2 2/38 (5.26%)  2 5/46 (10.87%)  5 0/36 (0.00%)  0
Dyspepsia  1  0/37 (0.00%)  0 0/38 (0.00%)  0 2/46 (4.35%)  2 2/36 (5.56%)  2
Flatulence  1  6/37 (16.22%)  6 2/38 (5.26%)  2 1/46 (2.17%)  1 0/36 (0.00%)  0
Nausea  1  14/37 (37.84%)  16 19/38 (50.00%)  22 24/46 (52.17%)  25 12/36 (33.33%)  13
Oral pain  1  0/37 (0.00%)  0 1/38 (2.63%)  1 1/46 (2.17%)  1 2/36 (5.56%)  2
Retching  1  2/37 (5.41%)  2 2/38 (5.26%)  2 1/46 (2.17%)  1 2/36 (5.56%)  2
Vomiting  1  5/37 (13.51%)  5 7/38 (18.42%)  8 9/46 (19.57%)  9 4/36 (11.11%)  4
General disorders         
Chest discomfort  1  0/37 (0.00%)  0 2/38 (5.26%)  2 0/46 (0.00%)  0 0/36 (0.00%)  0
Chills  1  1/37 (2.70%)  1 1/38 (2.63%)  1 5/46 (10.87%)  5 0/36 (0.00%)  0
Pyrexia  1  2/37 (5.41%)  2 3/38 (7.89%)  3 2/46 (4.35%)  2 3/36 (8.33%)  3
Injury, poisoning and procedural complications         
Anaemia postoperative  1  2/37 (5.41%)  2 2/38 (5.26%)  2 0/46 (0.00%)  0 1/36 (2.78%)  1
Gastrointestinal disorder postoperative  1  1/37 (2.70%)  1 0/38 (0.00%)  0 3/46 (6.52%)  3 0/36 (0.00%)  0
Incision site complication  1  9/37 (24.32%)  9 8/38 (21.05%)  8 10/46 (21.74%)  10 8/36 (22.22%)  8
Post procedural complication  1  2/37 (5.41%)  2 1/38 (2.63%)  1 0/46 (0.00%)  0 1/36 (2.78%)  1
Post procedural nausea  1  7/37 (18.92%)  8 5/38 (13.16%)  5 5/46 (10.87%)  5 2/36 (5.56%)  2
Procedural complication  1  2/37 (5.41%)  2 6/38 (15.79%)  6 2/46 (4.35%)  3 2/36 (5.56%)  2
Procedural hypertension  1  1/37 (2.70%)  1 2/38 (5.26%)  2 1/46 (2.17%)  1 1/36 (2.78%)  2
Procedural hypotension  1  0/37 (0.00%)  0 2/38 (5.26%)  2 1/46 (2.17%)  1 1/36 (2.78%)  1
Procedural pain  1  26/37 (70.27%)  36 29/38 (76.32%)  37 33/46 (71.74%)  38 24/36 (66.67%)  37
Investigations         
Blood creatine phosphokinase increased  1  2/37 (5.41%)  2 1/38 (2.63%)  1 0/46 (0.00%)  0 0/36 (0.00%)  0
Metabolism and nutrition disorders         
Hypocalcaemia  1  2/37 (5.41%)  2 1/38 (2.63%)  1 1/46 (2.17%)  1 0/36 (0.00%)  0
Hypomagnesaemia  1  2/37 (5.41%)  3 1/38 (2.63%)  1 0/46 (0.00%)  0 1/36 (2.78%)  1
Musculoskeletal and connective tissue disorders         
Back pain  1  3/37 (8.11%)  3 0/38 (0.00%)  0 2/46 (4.35%)  2 3/36 (8.33%)  3
Muscle spasms  1  0/37 (0.00%)  0 2/38 (5.26%)  2 0/46 (0.00%)  0 1/36 (2.78%)  1
Muscular weakness  1  4/37 (10.81%)  4 3/38 (7.89%)  3 2/46 (4.35%)  2 2/36 (5.56%)  2
Myalgia  1  1/37 (2.70%)  1 2/38 (5.26%)  2 4/46 (8.70%)  4 3/36 (8.33%)  3
Pain in extremity  1  0/37 (0.00%)  0 2/38 (5.26%)  2 1/46 (2.17%)  1 0/36 (0.00%)  0
Nervous system disorders         
Dizziness  1  0/37 (0.00%)  0 5/38 (13.16%)  5 5/46 (10.87%)  5 4/36 (11.11%)  4
Headache  1  3/37 (8.11%)  4 4/38 (10.53%)  4 12/46 (26.09%)  13 2/36 (5.56%)  2
Psychiatric disorders         
Abnormal dreams  1  0/37 (0.00%)  0 2/38 (5.26%)  2 2/46 (4.35%)  2 0/36 (0.00%)  0
Anxiety  1  0/37 (0.00%)  0 2/38 (5.26%)  2 2/46 (4.35%)  2 3/36 (8.33%)  5
Confusional state  1  0/37 (0.00%)  0 2/38 (5.26%)  2 1/46 (2.17%)  1 0/36 (0.00%)  0
Depression  1  0/37 (0.00%)  0 0/38 (0.00%)  0 0/46 (0.00%)  0 2/36 (5.56%)  2
Insomnia  1  5/37 (13.51%)  5 4/38 (10.53%)  4 4/46 (8.70%)  4 2/36 (5.56%)  2
Restlessness  1  0/37 (0.00%)  0 1/38 (2.63%)  1 1/46 (2.17%)  1 2/36 (5.56%)  2
Respiratory, thoracic and mediastinal disorders         
Pharyngolaryngeal pain  1  3/37 (8.11%)  3 4/38 (10.53%)  4 8/46 (17.39%)  8 7/36 (19.44%)  7
Wheezing  1  0/37 (0.00%)  0 2/38 (5.26%)  2 0/46 (0.00%)  0 0/36 (0.00%)  0
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  0/37 (0.00%)  0 2/38 (5.26%)  2 0/46 (0.00%)  0 0/36 (0.00%)  0
Pruritus  1  3/37 (8.11%)  3 4/38 (10.53%)  5 5/46 (10.87%)  5 2/36 (5.56%)  2
1
Term from vocabulary, MedDRA 9.1
Indicates events were collected by systematic assessment
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.
All publications including scientific papers, presentations, or other communication concerning the clinical trial must first be submitted to the Sponsor at least six weeks ahead of estimated publication or presentation, for written consent. In order to protect proprietary interests, the Sponsor shall have the right to make consent conditional upon proper representation of the interpretation of both the Sponsor and the investigator(s) in the discussion of the data in such communications.
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: NCT00473694     History of Changes
Other Study ID Numbers: P05945
19.4.302 ( Other Identifier: Organon Protocol Number )
P05945 ( Other Identifier: Schering-Plough Protocol Number )
MK-8616-025 ( Other Identifier: Merck Protocol Number )
First Submitted: May 14, 2007
First Posted: May 15, 2007
Results First Submitted: November 8, 2018
Results First Posted: March 7, 2019
Last Update Posted: March 19, 2019