A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy

Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model

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)

Time frame: Day of surgery (Day 0) up to 10 days in hospital

Mean Time to Discharge Order Written (DOW) Using KM Estimates

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)

Time frame: Day of surgery (Day 0) up to 10 days in hospital

Postoperative Length of Stay (LOS)

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).

Time frame: Day of surgery (Day 0) to the day of hospital DOW

Percentage of Participants Considered Postoperative LOS Responders

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.

Time frame: Day of surgery (Day 0) up to 7 days after surgery

Percentage of Participants With Postoperative Morbidity (POM)

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.

Time frame: During hospitalization or within 7 days after discharge

Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points

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.

Time frame: Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7

Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points

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.

Time frame: Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7

Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events

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.

Time frame: Baseline to 30 days post discharge