Trial Outcomes & Findings for A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy (NCT NCT00708201)
NCT ID: NCT00708201
Last Updated: 2016-01-08
Results Overview
Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement \[BM\]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum \[maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration\]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
280 participants
Primary outcome timeframe
From day of surgery (Day 0) up to 10 days in hospital
Results posted on
2016-01-08
Participant Flow
Participant milestones
| Measure |
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
137
|
143
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
130
|
137
|
|
Overall Study
COMPLETED
|
130
|
137
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy
Baseline characteristics by cohort
| Measure |
Placebo
n=137 Participants
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
n=143 Participants
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 9.84 • n=5 Participants
|
66.3 Years
STANDARD_DEVIATION 10.93 • n=7 Participants
|
65.1 Years
STANDARD_DEVIATION 10.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
134 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From day of surgery (Day 0) up to 10 days in hospitalPopulation: All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data. 39 participants in the Placebo group and 17 participants in the Alvimopan group were censored.
Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement \[BM\]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum \[maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration\]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)
Outcome measures
| Measure |
Placebo
n=134 Participants
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
n=143 Participants
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model
|
164.2 Hours
Standard Error 5.56
|
132.7 Hours
Standard Error 4.30
|
SECONDARY outcome
Timeframe: Day of surgery (Day 0) up to 10 days in hospitalPopulation: All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable ready to discharge data. 21 participants in the Placebo group and 12 participants in the Alvimopan group were censored.
The endpoint of "time to ready for discharge" was based solely on the recovery of GI function as determined by the surgeon. The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum \[maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration\]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)
Outcome measures
| Measure |
Placebo
n=134 Participants
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
n=143 Participants
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model
|
154.7 Hours
Standard Error 5.28
|
130.0 Hours
Standard Error 4.15
|
SECONDARY outcome
Timeframe: Day of surgery (Day 0) up to 10 days in hospitalPopulation: All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to DOW data. 36 participants in the Placebo group and 15 participants in the Alvimopan group were censored.
The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum \[maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration\]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)
Outcome measures
| Measure |
Placebo
n=134 Participants
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
n=143 Participants
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Mean Time to Discharge Order Written (DOW) Using KM Estimates
|
188.4 Hours
Standard Error 5.11
|
166.0 Hours
Standard Error 3.89
|
SECONDARY outcome
Timeframe: Day of surgery (Day 0) to the day of hospital DOWPopulation: All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.
The postoperative LOS was determined by the difference between the date of hospital DOW and the date of surgery; that is, the postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery).
Outcome measures
| Measure |
Placebo
n=134 Participants
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
n=143 Participants
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Postoperative Length of Stay (LOS)
|
10.07 Days
Standard Deviation 8.23
|
7.44 Days
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: Day of surgery (Day 0) up to 7 days after surgeryPopulation: All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.
A participant was considered a postoperative LOS responder if the postoperative LOS was less than or equal to 7 days. The postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery). Participants with missing data were considered nonresponders.
Outcome measures
| Measure |
Placebo
n=134 Participants
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
n=143 Participants
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Percentage of Participants Considered Postoperative LOS Responders
|
48.5 percentage of participants
|
67.1 percentage of participants
|
SECONDARY outcome
Timeframe: During hospitalization or within 7 days after dischargePopulation: All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable POM data.
POM was defined as the need for postoperative nasogastric (NG) tube insertion, hospital stay prolonged because of postoperative ileus (POI) (as determined by the investigator), or readmission (readmiss) to the hospital (hosp) for POI within 7 days (d) after discharge.
Outcome measures
| Measure |
Placebo
n=134 Participants
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
n=143 Participants
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Percentage of Participants With Postoperative Morbidity (POM)
Overall POM (n=134, 143)
|
29.1 percentage of participants
|
8.4 percentage of participants
|
|
Percentage of Participants With Postoperative Morbidity (POM)
Postoperative NG tube insertion (n=134, 143)
|
24.6 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Postoperative Morbidity (POM)
Prolonged hospital stay due to POI (n=133, 143)
|
21.8 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants With Postoperative Morbidity (POM)
POI rslt in readmiss to hosp in ≤7days(n=134,143)
|
0.8 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7Population: All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.
Time to achieve recovery of GI function was measured by a composite endpoint of time to first BM and time to tolerate first solid food (solids). This endpoint was referred to as GI2, and GI2 was calculated as follows: GI2 = max (solids, BM). GI2 responders were defined as those participants who met all the following criteria: achieved GI2 by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. Postsurgery Days (PSD) were measured in 24 hour increments after surgery.
Outcome measures
| Measure |
Placebo
n=134 Participants
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
n=143 Participants
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points
PSD 3
|
9.7 percentage of participants
|
25.2 percentage of participants
|
|
Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points
PSD 4
|
27.6 percentage of participants
|
53.8 percentage of participants
|
|
Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points
PSD 5
|
42.5 percentage of participants
|
75.5 percentage of participants
|
|
Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points
PSD 6
|
53.0 percentage of participants
|
79.7 percentage of participants
|
|
Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points
PSD 7
|
57.5 percentage of participants
|
84.6 percentage of participants
|
SECONDARY outcome
Timeframe: Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7Population: All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.
DOW responders were defined as those participants who met all the following criteria: achieved DOW by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. PSD were measured in 24 hour increments after surgery.
Outcome measures
| Measure |
Placebo
n=134 Participants
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
n=143 Participants
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points
PSD 3
|
0.7 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points
PSD 4
|
17.9 percentage of participants
|
14 percentage of participants
|
|
Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points
PSD 5
|
32.1 percentage of participants
|
39.9 percentage of participants
|
|
Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points
PSD 6
|
47.8 percentage of participants
|
62.2 percentage of participants
|
|
Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points
PSD 7
|
55.2 percentage of participants
|
80.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 30 days post dischargePopulation: All participants who received at least 1 dose of study medication.
CV events of interest included congestive heart failure, CV death, cerebrovascular accident, myocardial infarction, serious arrhythmia, and unstable angina. CV events were adjudicated by a blinded external committee.
Outcome measures
| Measure |
Placebo
n=137 Participants
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
n=143 Participants
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events
Overall CV events of interest
|
15.3 percentage of participants
|
8.4 percentage of participants
|
|
Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events
Congestive heart failure
|
2.9 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events
CV death
|
2.9 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events
Cerebrovascular accident
|
0.7 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events
Myocardial infarction
|
7.3 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events
Serious arrhythmia
|
5.1 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events
Unstable angina
|
0.7 percentage of participants
|
0.7 percentage of participants
|
Adverse Events
Placebo
Serious events: 67 serious events
Other events: 128 other events
Deaths: 0 deaths
Alvimopan 12 mg
Serious events: 51 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=137 participants at risk
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
n=143 participants at risk
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
1.5%
2/137 • Number of events 2
|
0.00%
0/143
|
|
Cardiac disorders
Cardiac Arrest
|
1.5%
2/137 • Number of events 2
|
0.00%
0/143
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Cardiac disorders
Myocardial Infarction
|
1.5%
2/137 • Number of events 2
|
1.4%
2/143 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.5%
2/137 • Number of events 2
|
0.00%
0/143
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Congenital, familial and genetic disorders
Gastrointestinal Angiodysplasia Haemorrhagic
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
2/137 • Number of events 2
|
1.4%
2/143 • Number of events 2
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
0.73%
1/137 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
|
Gastrointestinal disorders
Enterovesical Fistula
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
5.1%
7/137 • Number of events 7
|
0.70%
1/143 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
General disorders
Device Malfunction
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
General disorders
Non-Cardiac Chest Pain
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
General disorders
Pyrexia
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
General disorders
Sudden Death
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Hepatobiliary disorders
Hepatitis Chronic Active
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Infections and infestations
Abdominal Abscess
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
0.73%
1/137 • Number of events 1
|
1.4%
2/143 • Number of events 2
|
|
Infections and infestations
Clostridial Infection
|
1.5%
2/137 • Number of events 2
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.73%
1/137 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
Fungal Oesophagitis
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
Fungal Sepsis
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
Incision Site Infection
|
0.73%
1/137 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
Pelvic Abscess
|
1.5%
2/137 • Number of events 2
|
2.1%
3/143 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Infections and infestations
Postoperative Wound Infection
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Infections and infestations
Pyelonephritis
|
0.73%
1/137 • Number of events 1
|
2.8%
4/143 • Number of events 4
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
Retroperitoneal Abscess
|
0.00%
0/137
|
1.4%
2/143 • Number of events 2
|
|
Infections and infestations
Sepsis
|
2.2%
3/137 • Number of events 3
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
Septic Shock
|
0.00%
0/137
|
1.4%
2/143 • Number of events 2
|
|
Infections and infestations
Urinary Tract Infection
|
1.5%
2/137 • Number of events 2
|
3.5%
5/143 • Number of events 5
|
|
Infections and infestations
Urinary Tract Infection Enterococcal
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Infections and infestations
Urinary Tract Infection Staphylococcal
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
0.73%
1/137 • Number of events 1
|
1.4%
2/143 • Number of events 2
|
|
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence
|
1.5%
2/137 • Number of events 2
|
0.70%
1/143 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Injury, poisoning and procedural complications
Gastrointestinal Anastomotic Leak
|
0.73%
1/137 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Injury, poisoning and procedural complications
Postoperative Fever
|
1.5%
2/137 • Number of events 2
|
0.00%
0/143
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
20.4%
28/137 • Number of events 29
|
4.9%
7/143 • Number of events 8
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Injury, poisoning and procedural complications
Urinary Anastomotic Leak
|
1.5%
2/137 • Number of events 2
|
0.00%
0/143
|
|
Injury, poisoning and procedural complications
Urinary Retention Postoperative
|
0.73%
1/137 • Number of events 1
|
1.4%
2/143 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
1.5%
2/137 • Number of events 2
|
1.4%
2/143 • Number of events 2
|
|
Investigations
Clostridium Test Positive
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Investigations
Culture Positive
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Investigations
Staphylococcus Test Positive
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
7/137 • Number of events 7
|
2.1%
3/143 • Number of events 3
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
1.5%
2/137 • Number of events 2
|
0.00%
0/143
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.73%
1/137 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat Cancer
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Nervous system disorders
Dizziness
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Nervous system disorders
Presyncope
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Psychiatric disorders
Completed Suicide
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.73%
1/137 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Renal and urinary disorders
Renal Failure
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.2%
3/137 • Number of events 3
|
2.1%
3/143 • Number of events 3
|
|
Renal and urinary disorders
Urinoma
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Reproductive system and breast disorders
Pelvic Fluid Collection
|
1.5%
2/137 • Number of events 2
|
1.4%
2/143 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/137
|
1.4%
2/143 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.6%
5/137 • Number of events 5
|
0.70%
1/143 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/137
|
0.70%
1/143 • Number of events 1
|
|
Surgical and medical procedures
Abdominal Cavity Drainage
|
0.73%
1/137 • Number of events 1
|
0.00%
0/143
|
|
Vascular disorders
Deep Vein Thrombosis
|
3.6%
5/137 • Number of events 5
|
0.70%
1/143 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.73%
1/137 • Number of events 1
|
1.4%
2/143 • Number of events 2
|
Other adverse events
| Measure |
Placebo
n=137 participants at risk
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
|
Alvimopan 12 mg
n=143 participants at risk
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypokalaemia
|
29.2%
40/137 • Number of events 40
|
18.9%
27/143 • Number of events 27
|
|
Blood and lymphatic system disorders
Anaemia
|
24.8%
34/137 • Number of events 34
|
18.9%
27/143 • Number of events 27
|
|
Gastrointestinal disorders
Nausea
|
23.4%
32/137 • Number of events 32
|
10.5%
15/143 • Number of events 15
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
17.5%
24/137 • Number of events 24
|
14.7%
21/143 • Number of events 21
|
|
Psychiatric disorders
Insomnia
|
14.6%
20/137 • Number of events 20
|
13.3%
19/143 • Number of events 19
|
|
General disorders
Pyrexia
|
14.6%
20/137 • Number of events 20
|
12.6%
18/143 • Number of events 18
|
|
Gastrointestinal disorders
Constipation
|
13.9%
19/137 • Number of events 19
|
14.7%
21/143 • Number of events 21
|
|
Infections and infestations
Urinary Tract Infection
|
13.1%
18/137 • Number of events 18
|
7.7%
11/143 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhoea
|
12.4%
17/137 • Number of events 17
|
9.1%
13/143 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.4%
17/137 • Number of events 17
|
13.3%
19/143 • Number of events 19
|
|
General disorders
Oedema Peripheral
|
12.4%
17/137 • Number of events 17
|
6.3%
9/143 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.4%
17/137 • Number of events 17
|
7.0%
10/143 • Number of events 10
|
|
Cardiac disorders
Tachycardia
|
11.7%
16/137 • Number of events 16
|
9.1%
13/143 • Number of events 13
|
|
Gastrointestinal disorders
Flatulence
|
10.2%
14/137 • Number of events 14
|
4.9%
7/143 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.2%
14/137 • Number of events 14
|
10.5%
15/143 • Number of events 15
|
|
Vascular disorders
Hypotension
|
9.5%
13/137 • Number of events 13
|
9.1%
13/143 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.8%
12/137 • Number of events 12
|
8.4%
12/143 • Number of events 12
|
|
Injury, poisoning and procedural complications
Anaemia Postoperative
|
8.0%
11/137 • Number of events 11
|
6.3%
9/143 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.0%
11/137 • Number of events 11
|
0.70%
1/143 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
11/137 • Number of events 11
|
2.8%
4/143 • Number of events 4
|
|
Vascular disorders
Hypertension
|
7.3%
10/137 • Number of events 10
|
9.1%
13/143 • Number of events 13
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.6%
9/137 • Number of events 9
|
4.2%
6/143 • Number of events 6
|
|
Psychiatric disorders
Anxiety
|
6.6%
9/137 • Number of events 9
|
8.4%
12/143 • Number of events 12
|
|
Gastrointestinal disorders
Dyspepsia
|
6.6%
9/137 • Number of events 9
|
4.2%
6/143 • Number of events 6
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.6%
9/137 • Number of events 9
|
1.4%
2/143 • Number of events 2
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
6.6%
9/137 • Number of events 9
|
2.8%
4/143 • Number of events 4
|
|
Investigations
Haemoglobin Decreased
|
5.8%
8/137 • Number of events 8
|
2.8%
4/143 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.8%
8/137 • Number of events 8
|
4.2%
6/143 • Number of events 6
|
|
Metabolism and nutrition disorders
Malnutrition
|
5.8%
8/137 • Number of events 8
|
2.1%
3/143 • Number of events 3
|
|
Renal and urinary disorders
Renal Failure Acute
|
5.8%
8/137 • Number of events 8
|
4.2%
6/143 • Number of events 6
|
|
Cardiac disorders
Sinus Tachycardia
|
5.8%
8/137 • Number of events 8
|
2.1%
3/143 • Number of events 3
|
|
Investigations
Blood Creatinine Increased
|
5.1%
7/137 • Number of events 7
|
2.8%
4/143 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.1%
7/137 • Number of events 7
|
3.5%
5/143 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.1%
7/137 • Number of events 7
|
3.5%
5/143 • Number of events 5
|
|
Investigations
Troponin Increased
|
5.1%
7/137 • Number of events 7
|
3.5%
5/143 • Number of events 5
|
|
Investigations
Urine Output Decreased
|
5.1%
7/137 • Number of events 7
|
4.2%
6/143 • Number of events 6
|
Additional Information
Vice President, Clinical Research
Cubist Pharmaceuticals
Phone: (781) 860-8660
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place