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Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by:

Cubist Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01150760

First received: June 23, 2010

Last updated: September 8, 2010

Last verified: September 2010

History of Changes

Results First Received: August 17, 2010

Study Type:	Observational
Study Design:	Observational Model: Case Control; Time Perspective: Retrospective
Condition:	Ileus
Intervention:	Drug: Alvimopan

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Participant Flow: Overall Study

	Alvimopan Users	Matched Controls
STARTED	3525	3525
COMPLETED	3525	3525
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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
Total	Total of all reporting groups

Baseline Measures

	Alvimopan Users	Matched Controls	Total
Number of Participants [units: participants]	3525	3525	7050
Age [units: years] Mean ± Standard Deviation	61.9 ± 14.1	61.8 ± 14.7	61.9 ± 14.4
Gender [units: participants]
Female	1847	1872	3719
Male	1678	1653	3331
Race (NIH/OMB) [units: Participants]
Black or African American	331	368	699
White	2675	2543	5218
Other	519	614	1133
Procedure type ^[1] [units: Participants]
Laparoscopic colon or rectal resection	1427	1427	2854
Open colon or rectal resection	1171	1171	2342
Laparoscopic or open colon or rectal resection	424	424	848
Laparoscopic or open small bowel resection	181	181	362
Laparoscopic or open ostomy takedown, bypass,other	322	322	644
Surgeon type ^[2] [units: Participants]
General surgeon	1809	1809	3618
Colorectal surgeon	1357	1357	2714
Other	359	359	718

[1]	Category of bowel resection that patients underwent during their hospitalization
[2]	The type of surgeon that performed the patient's bowel resection during their hospitalization

Outcome Measures

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1. Primary:

Percentage of Patients Who Died [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type	Primary
Measure Title	Percentage of Patients Who Died
Measure Description	All-cause
Time Frame	Participants were followed up until their hospital discharge after bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Percentage of Patients Who Died [units: Percent of participants]	0.4	1.0

Statistical Analysis 1 for Percentage of Patients Who Died

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.0007
Mean Difference (Net) ^[4]	-0.6

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

2. Primary:

Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type	Primary
Measure Title	Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity
Measure Description	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.
Time Frame	Participants were followed up until their hospital discharge after bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity [units: Percent of participants]	29.8	35.7

Statistical Analysis 1 for Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	< 0.0001
Mean Difference (Net) ^[4]	-5.9

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

3. Primary:

Percentage of Patients With In-hospital Cardiovascular Morbidity [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type	Primary
Measure Title	Percentage of Patients With In-hospital Cardiovascular Morbidity
Measure Description	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).
Time Frame	Participants were followed up until their hospital discharge after bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Percentage of Patients With In-hospital Cardiovascular Morbidity [units: Percent of participants]	19.4	24.0

Statistical Analysis 1 for Percentage of Patients With In-hospital Cardiovascular Morbidity

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.0001
Mean Difference (Net) ^[4]	-4.6

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

4. Primary:

Percentage of Patients With In-hospital Cerebrovascular Morbidity [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type	Primary
Measure Title	Percentage of Patients With In-hospital Cerebrovascular Morbidity
Measure Description	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.
Time Frame	Participants were followed up until their hospital discharge after bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Percentage of Patients With In-hospital Cerebrovascular Morbidity [units: Percent of participants]	0.2	0.5

Statistical Analysis 1 for Percentage of Patients With In-hospital Cerebrovascular Morbidity

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.1022
Mean Difference (Net) ^[4]	-0.3

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

5. Primary:

Percentage of Patients With In-hospital Pulmonary Morbidity [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type	Primary
Measure Title	Percentage of Patients With In-hospital Pulmonary Morbidity
Measure Description	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.
Time Frame	Participants were followed up until their hospital discharge after bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Percentage of Patients With In-hospital Pulmonary Morbidity [units: Percent of participants]	7.3	10.5

Statistical Analysis 1 for Percentage of Patients With In-hospital Pulmonary Morbidity

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	< 0.0001
Mean Difference (Net) ^[4]	-3.2

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

6. Primary:

Percentage of Patients With In-hospital Infection Morbidity [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type	Primary
Measure Title	Percentage of Patients With In-hospital Infection Morbidity
Measure Description	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.
Time Frame	Participants were followed up until their hospital discharge after bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Percentage of Patients With In-hospital Infection Morbidity [units: Percent of participants]	9.2	11.5

Statistical Analysis 1 for Percentage of Patients With In-hospital Infection Morbidity

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.0012
Mean Difference (Net) ^[4]	-2.3

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

7. Primary:

Percentage of Patients With In-hospital Thromboembolic Morbidity [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type	Primary
Measure Title	Percentage of Patients With In-hospital Thromboembolic Morbidity
Measure Description	Thromboembolic morbidity was identified using ICD-9-CM diagnosis and procedure codes for pulmonary embolishm 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.
Time Frame	Participants were followed up until their hospital discharge after bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Percentage of Patients With In-hospital Thromboembolic Morbidity [units: Percent of participants]	1.2	2.1

Statistical Analysis 1 for Percentage of Patients With In-hospital Thromboembolic Morbidity

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.0030
Mean Difference (Net) ^[4]	-0.9

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

8. Primary:

Percentage of Patients With In-hospital Other Morbidity [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type	Primary
Measure Title	Percentage of Patients With In-hospital Other Morbidity
Measure Description	Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complicaitons not elsewhere classified.
Time Frame	Participants were followed up until their hospital discharge after bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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 alvimpan cohort] during their hospitalization)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Percentage of Patients With In-hospital Other Morbidity [units: Percent of participants]	0.6	0.7

Statistical Analysis 1 for Percentage of Patients With In-hospital Other Morbidity

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.7637
Mean Difference (Net) ^[4]	-0.1

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

9. Primary:

Percentage of Patients Who Were Readmitted Within 15 Days of Discharge [ Time Frame: Within 15 days of discharge from hospitalization for bowel resection ]

Measure Type	Primary
Measure Title	Percentage of Patients Who Were Readmitted Within 15 Days of Discharge
Measure Description	No text entered.
Time Frame	Within 15 days of discharge from hospitalization for bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Percentage of Patients Who Were Readmitted Within 15 Days of Discharge [units: Percent of partcipants]	7.4	8.7

Statistical Analysis 1 for Percentage of Patients Who Were Readmitted Within 15 Days of Discharge

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.0402
Mean Difference (Net) ^[4]	-1.3

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

10. Primary:

Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge [ Time Frame: Between 16-30 days after hospital discharge after bowel resection ]

Measure Type	Primary
Measure Title	Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge
Measure Description	No text entered.
Time Frame	Between 16-30 days after hospital discharge after bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge [units: Percent of participants]	1.9	2.5

Statistical Analysis 1 for Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.0755
Mean Difference (Net) ^[4]	-0.6

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

11. Primary:

Percentage of Patients Who Were Readmitted Within 30 Days of Discharge [ Time Frame: Between 0-30 days after hospital discharge after bowel resection ]

Measure Type	Primary
Measure Title	Percentage of Patients Who Were Readmitted Within 30 Days of Discharge
Measure Description	No text entered.
Time Frame	Between 0-30 days after hospital discharge after bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Percentage of Patients Who Were Readmitted Within 30 Days of Discharge [units: Percent of participants]	9.3	11.2

Statistical Analysis 1 for Percentage of Patients Who Were Readmitted Within 30 Days of Discharge

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.0532
Mean Difference (Net) ^[4]	-1.9

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

12. Primary:

Percentage of Patients Discharged to Various Locations [ Time Frame: Hospital discharge after bowel resection ]

Measure Type	Primary
Measure Title	Percentage of Patients Discharged to Various Locations
Measure Description	Location of discharge for patients who were admitted to the hospital for their bowel resection from home
Time Frame	Hospital discharge after bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Percentage of Patients Discharged to Various Locations [units: Percent of participants]
Health care facility	7.9	13.8
Home	87.5	80.7

Statistical Analysis 1 for Percentage of Patients Discharged to Various Locations

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	< 0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

13. Primary:

Intensive Care Unit Length of Stay [ Time Frame: Participants were followed up until their hospital discharge after bowel resection ]

Measure Type	Primary
Measure Title	Intensive Care Unit Length of Stay
Measure Description	No text entered.
Time Frame	Participants were followed up until their hospital discharge after bowel resection
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	3525	3525
Intensive Care Unit Length of Stay [units: Days] Mean ± Standard Deviation	0.3 ± 1.4	0.6 ± 2.4

Statistical Analysis 1 for Intensive Care Unit Length of Stay

Groups ^[1]	All groups
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	< 0.0001
Mean Difference (Net) ^[4]	-0.3

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

14. Secondary:

Postoperative Length of Hospital Stay [ Time Frame: Measured from the day after bowel resection to the day of hospital discharge ]

Measure Type	Secondary
Measure Title	Postoperative Length of Hospital Stay
Measure Description	Calendar day of discharge - calendar day of surgery = postoperative length of stay
Time Frame	Measured from the day after bowel resection to the day of hospital discharge
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)

Reporting Groups

	Description
Alvimopan Users	Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
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

Measured Values

	Alvimopan Users	Matched Controls
Number of Participants Analyzed [units: participants]	2323	2323
Postoperative Length of Hospital Stay [units: Days] Mean ± Standard Deviation	5.3 ± 3.1	6.4 ± 4.8

Statistical Analysis 1 for Postoperative Length of Hospital Stay

Groups ^[1]	All groups
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	< 0.0001
Mean Difference (Net) ^[4]	-1.1

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
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Serious Adverse Events

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Director Medical Writing and Scientific Communications
Organization: Adolor Corporation
phone: 484-595-1942
e-mail: arachfal@adolor.com

No publications provided by Cubist Pharmaceuticals

Publications automatically indexed to this study:

Delaney CP, Craver C, Gibbons MM, Rachfal AW, VandePol CJ, Cook SF, Poston SA, Calloway M, Techner L. Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection. Ann Surg. 2012 Apr;255(4):731-8.

Responsible Party:	Adolor
ClinicalTrials.gov Identifier:	NCT01150760 History of Changes
Other Study ID Numbers:	Premier clinical outcomes
Study First Received:	June 23, 2010
Results First Received:	August 17, 2010
Last Updated:	September 8, 2010
Health Authority:	United States: Institutional Review Board

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