| Primary | Percentage of Patients Who Died | | Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization) | Posted | | Number | | Percent of participants | | Participants were followed up until their hospital discharge after bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Chi-squared | | 0.0007 | | Mean Difference (Net) | -0.6 | | | | | | | | | | No | Superiority or Other | | |
|
| Primary | Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity | GI morbidity will be identified using International Classification of Disease 9th Edition Clinical Modification (ICD-9-CM) diagnosis and procedure codes for paralytic ileus, flatulence, eructation, gas pain, insertion of a nasogastric tube, total parenteral nutrition, peripheral parenteral nutrition, digestive symptom complications, diarrhea following GI surgery, intestinal obstruction, abdominal pain, peritoneal adhesions, unspecified protein-calorie malnutrition, parenteral infusion of concentrated nutritional substances, or enteral infusion of concentrated nutritional substances. | Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization) | Posted | | Number | | Percent of participants | | Participants were followed up until their hospital discharge after bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
|
| Primary | Percentage of Patients With In-hospital Cardiovascular Morbidity | Cardiovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for myocardial infarction; other ischemic events; congestive heart failure and shock; arrhythmias; or other cardiovascular events (cardiac complications, peripheral vascular complications). | Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization) | Posted | | Number | | Percent of participants | | Participants were followed up until their hospital discharge after bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| |
| Primary | Percentage of Patients With In-hospital Cerebrovascular Morbidity | Cerebrovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for ischemic, thrombotic, embolic or hemorrhagic cerebrovascular accidents; acute but ill-defined cerebrovascular disease; transient cerebral ischemia; syncope; or postoperative cerebrovascular accident. | Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization) | Posted | | Number | | Percent of participants | | Participants were followed up until their hospital discharge after bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| |
| Primary | Percentage of Patients With In-hospital Pulmonary Morbidity | Pulmonary morbidity was identified using ICD-9-CM diagnosis and procedure codes for pneumonia; infectious pneumonia; respiratory complications, pulmonary collapse; acute respiratory failure or edema; pulmonary congestion and hypostasis; pulmonary/respiratory insufficiency after trauma and/or surgery; dyspnea; or respiratory arrest; transfusion related acute lung injury. | Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization) | Posted | | Number | | Percent of participants | | Participants were followed up until their hospital discharge after bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| |
| Secondary | Postoperative Length of Hospital Stay | Calendar day of discharge - calendar day of surgery = postoperative length of stay | Modified intent-to-treat (included patients who met all base population, inclusion and exclusion criteria, received ≥ 3 and ≤ 15 doses of alvimopan [for alvimopan cohort] during the patient's hospitalization, and received parenteral opioid on ≥ 1 postoperative day) | Posted | Aug 2010 | Mean | Standard Deviation | Days | | Measured from the day after bowel resection to the day of hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| |
| Primary | Percentage of Patients With In-hospital Infection Morbidity | Infection morbidity was identified using ICD-9-CM diagnosis and procedure codes for infection due to central venous catheter; abscess of intestine; peritoneal abscess; sepsis or severe sepsis; infection due to vascular device, implant and graft; urinary tract infection; disruption of internal or external surgical wound; persistent postoperative fistula; or postoperative infection. | Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization) | Posted | | Number | | Percent of participants | | Participants were followed up until their hospital discharge after bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| |
| Primary | Percentage of Patients With In-hospital Thromboembolic Morbidity | Thromboembolic morbidity was identified using ICD-9-CM diagnosis and procedure codes for pulmonary embolism and infarction; arterial embolism and thrombosis or thrombosis of the lower extremities; vascular disorders of the kidney; acute vascular insufficiency of the intestine; or venous thromboembolism. | Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization) | Posted | | Number | | Percent of participants | | Participants were followed up until their hospital discharge after bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| |
| Primary | Percentage of Patients With In-hospital Other Morbidity | Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complications not elsewhere classified. | Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization) | Posted | | Number | | Percent of participants | | Participants were followed up until their hospital discharge after bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| |
| Primary | Percentage of Patients Who Were Readmitted Within 15 Days of Discharge | | Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization) | Posted | Aug 2010 | Number | | Percent of partcipants | | Within 15 days of discharge from hospitalization for bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| |
| Primary | Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge | | Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization) | Posted | Aug 2010 | Number | | Percent of participants | | Between 16-30 days after hospital discharge after bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| |
| Primary | Percentage of Patients Who Were Readmitted Within 30 Days of Discharge | | Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization) | Posted | Aug 2010 | Number | | Percent of participants | | Between 0-30 days after hospital discharge after bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| |
| Primary | Percentage of Patients Discharged to Various Locations | Location of discharge for patients who were admitted to the hospital for their bowel resection from home | Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization) | Posted | Aug 2010 | Number | | Percent of participants | | Hospital discharge after bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| |
| Primary | Intensive Care Unit Length of Stay | | Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization) | Posted | Aug 2010 | Mean | Standard Deviation | Days | | Participants were followed up until their hospital discharge after bowel resection | | | | ID | Title | Description |
|---|
| OG000 | Alvimopan Users | Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) | | OG001 | Matched Controls | Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan |
| |