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| ID | Type | Description | Link |
|---|---|---|---|
| 14CL403 | Other Identifier | Cubist Study Number |
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This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alvimopan | Experimental | 12 milligrams (mg) Alvimopan, 12mg, capsule. Administered orally. One 30 minutes to 5 hours before the scheduled start of surgery on Day 0, and twice daily beginning on Postoperative Day 1 (POD 1) until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment |
|
| Placebo | Placebo Comparator | 300 mg polyethylene glycol in a capsule 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alvimopan | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model | 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) | From day of surgery (Day 0) up to 10 days in hospital |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Techner, DPM | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saddleback Memorial Medical Center | Laguna Hills | California | 92653 | United States | ||
| University of Colorado Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24630419 | Derived | Lee CT, Chang SS, Kamat AM, Amiel G, Beard TL, Fergany A, Karnes RJ, Kurz A, Menon V, Sexton WJ, Slaton JW, Svatek RS, Wilson SS, Techner L, Bihrle R, Steinberg GD, Koch M. Alvimopan accelerates gastrointestinal recovery after radical cystectomy: a multicenter randomized placebo-controlled trial. Eur Urol. 2014 Aug;66(2):265-72. doi: 10.1016/j.eururo.2014.02.036. Epub 2014 Feb 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Alvimopan 12 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| 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) | 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). | 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. | 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. | 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. | 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. | 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. | Baseline to 30 days post discharge |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Miami | Miami | Florida | 33136 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| University of Chicago, Section of Urology MC6038 | Chicago | Illinois | 60637 | United States |
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota Hospital | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| CRC of Jackson | Jackson | Mississippi | 39202 | United States |
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27599 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Bend Memorial Clinic | Bend | Oregon | 97701 | United States |
| Oregon Health and Science University Knight Cancer Institute | Portland | Oregon | 97239 | United States |
| Vanderbilt University Medical Center, Department of Urology Surgery | Nashville | Tennessee | 37232 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All study participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model | 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) | 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. | Posted | Mean | Standard Error | Hours | From day of surgery (Day 0) up to 10 days in hospital |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | 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. | Posted | Mean | Standard Error | Hours | Day of surgery (Day 0) up to 10 days in hospital |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | 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. | Posted | Mean | Standard Error | Hours | Day of surgery (Day 0) up to 10 days in hospital |
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| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | Days | Day of surgery (Day 0) to the day of hospital DOW |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | percentage of participants | Day of surgery (Day 0) up to 7 days after surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | percentage of participants | During hospitalization or within 7 days after discharge |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | percentage of participants | Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7 |
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| Secondary | 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. | 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. | Posted | Number | percentage of participants | Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7 |
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| Secondary | 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. | All participants who received at least 1 dose of study medication. | Posted | Number | percentage of participants | Baseline to 30 days post discharge |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 67 | 137 | 128 | 137 | ||
| EG001 | 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. | 51 | 143 | 127 | 143 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Acute Coronary Syndrome | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA 14.1 | Systematic Assessment | Resulted in two deaths |
|
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 14.1 | Systematic Assessment | Resulted in one death |
|
| Myocardial Infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment | Resulted in one death |
|
| Tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gastrointestinal Angiodysplasia Haemorrhagic | Congenital, familial and genetic disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Enterocutaneous Fistula | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Enterovesical Fistula | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Device Malfunction | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA 14.1 | Systematic Assessment | Resulted in one death |
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| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
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| Hepatitis Chronic Active | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal Abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Abdominal Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Clostridial Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Clostridium Difficile Colitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Fungal Oesophagitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Fungal Sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Incision Site Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Pelvic Abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment | Resulted in one death |
|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Postoperative Wound Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Pyelonephritis Acute | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Retroperitoneal Abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment | Resulted in one death |
|
| Septic Shock | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary Tract Infection Enterococcal | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Urinary Tract Infection Staphylococcal | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment | Resulted in one death |
|
| Abdominal Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Gastrointestinal Anastomotic Leak | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Gun Shot Wound | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment | Resulted in one death |
|
| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Postoperative Fever | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Postoperative Wound Complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Procedural Hypotension | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Toxicity To Various Agents | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Urinary Anastomotic Leak | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Urinary Retention Postoperative | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Clostridium Test Positive | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Culture Positive | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Staphylococcus Test Positive | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Failure To Thrive | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Throat Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment | Resulted in one death |
|
| Cerebral Infarction | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment | Resulted in one death |
|
| Delirium | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Urinoma | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pelvic Fluid Collection | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment | Resulted in one death |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment | Resulted in one death |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal Cavity Drainage | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment | Resulted in one death |
|
| Hypotension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anaemia Postoperative | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Troponin Increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Urine Output Decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Research | Cubist Pharmaceuticals | (781) 860-8660 |
| ID | Term |
|---|---|
| D045823 | Ileus |
| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C419502 | alvimopan |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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