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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOA-728 12 mg QD | Experimental | Participants will receive MOA-728 12 milligrams (mg) SC once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-methylnaltrexone bromide (MOA-728) | Drug | MOA-728 will be administered as per the dose and schedule specified in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as an AE that emerged during the treatment period. Any TEAEs included both treatment-emergent SAEs and non-serious AEs. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module. | Baseline up to Week 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up | Weekly BM rate was derived as the total number of BMs reported in a month divided by the total number of days with non-missing BM diary information in the same month, then multiplied by 7 to normalize to a weekly rate. If the total number of days with non-missing BM diary information in a given month was less than 10 days, the weekly BM rate for the month was defined as missing. The weekly BM rate at baseline was calculated based on the screening period (Days -14 to -1). If the total number of days with non-missing BM diary information during the screening period was less than 5 days, the weekly BM rate at baseline was defined as missing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Mathew | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35242 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21429809 | Result | Michna E, Blonsky ER, Schulman S, Tzanis E, Manley A, Zhang H, Iyer S, Randazzo B. Subcutaneous methylnaltrexone for treatment of opioid-induced constipation in patients with chronic, nonmalignant pain: a randomized controlled study. J Pain. 2011 May;12(5):554-62. doi: 10.1016/j.jpain.2010.11.008. Epub 2011 Mar 22. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 1040 participants who met the inclusion/exclusion criteria were assigned to receive treatment and 1034 of these participants received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | MOA-728 12 mg QD | Participants received N-methylnaltrexone bromide (MOA-728, MNTX) 12 milligrams (mg) subcutaneously (SC) once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline, follow-up (14 days [Week 49 to 50]) |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Pfizer Investigational Site | Mesa | Arizona | 85206 | United States |
| Pfizer Investigational Site | Mesa | Arizona | 85213 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85028 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85029 | United States |
| Pfizer Investigational Site | Tempe | Arizona | 85282 | United States |
| Pfizer Investigational Site | Tucson | Arizona | 85710 | United States |
| Pfizer Investigational Site | Tucson | Arizona | 85741 | United States |
| Pfizer Investigational Site | Hot Springs | Arkansas | 71913 | United States |
| Pfizer Investigational Site | Garden Grove | California | 92843 | United States |
| Pfizer Investigational Site | Laguna Hills | California | 92653 | United States |
| Pfizer Investigational Site | Los Gatos | California | 95032 | United States |
| Pfizer Investigational Site | Newport Beach | California | 92660 | United States |
| Pfizer Investigational Site | Newport Beach | California | 92663 | United States |
| Pfizer Investigational Site | Colorado Springs | Colorado | 80904 | United States |
| Pfizer Investigational Site | Boca Raton | Florida | 33432 | United States |
| Pfizer Investigational Site | Brandon | Florida | 33511 | United States |
| Pfizer Investigational Site | Chiefland | Florida | 32626 | United States |
| Pfizer Investigational Site | Clearwater | Florida | 33756 | United States |
| Pfizer Investigational Site | Daytona Beach | Florida | 32117 | United States |
| Pfizer Investigational Site | Fort Myers | Florida | 33916 | United States |
| Pfizer Investigational Site | Gainesville | Florida | 32607 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32216 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32257 | United States |
| Pfizer Investigational Site | Jupiter | Florida | 33458 | United States |
| Pfizer Investigational Site | Miami | Florida | 33180 | United States |
| Pfizer Investigational Site | Miami | Florida | 33183 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34471-2106 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34471 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34474 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32806 | United States |
| Pfizer Investigational Site | Ormond Beach | Florida | 32174 | United States |
| Pfizer Investigational Site | Port Orange | Florida | 32129 | United States |
| Pfizer Investigational Site | Sarasota | Florida | 34231 | United States |
| Pfizer Investigational Site | Sarasota | Florida | 34239 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33603 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33613 | United States |
| Pfizer Investigational Site | Vero Beach | Florida | 32960 | United States |
| Pfizer Investigational Site | Winter Park | Florida | 32789 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60616 | United States |
| Pfizer Investigational Site | Rockford | Illinois | 61107 | United States |
| Pfizer Investigational Site | Avon | Indiana | 46123 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47714 | United States |
| Pfizer Investigational Site | Indianapolis | Indiana | 46205 | United States |
| Pfizer Investigational Site | Indianapolis | Indiana | 46250 | United States |
| Pfizer Investigational Site | West Des Moines | Iowa | 50265 | United States |
| Pfizer Investigational Site | Madisonville | Kentucky | 42431 | United States |
| Pfizer Investigational Site | Hagerstown | Maryland | 21742 | United States |
| Pfizer Investigational Site | Hollywood | Maryland | 20636 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02115 | United States |
| Pfizer Investigational Site | Brockton | Massachusetts | 02301 | United States |
| Pfizer Investigational Site | Watertown | Massachusetts | 02472 | United States |
| Pfizer Investigational Site | Bingham Farms | Michigan | 48025 | United States |
| Pfizer Investigational Site | Chesterfield | Michigan | 48047 | United States |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49009 | United States |
| Pfizer Investigational Site | Traverse City | Michigan | 49684 | United States |
| Pfizer Investigational Site | Edina | Minnesota | 55435 | United States |
| Pfizer Investigational Site | Biloxi | Mississippi | 39531 | United States |
| Pfizer Investigational Site | Jackson | Mississippi | 39202 | United States |
| Pfizer Investigational Site | Springfield | Missouri | 65807 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68131 | United States |
| Pfizer Investigational Site | Henderson | Nevada | 89014 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89119 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89123 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89146 | United States |
| Pfizer Investigational Site | Elizabeth | New Jersey | 07202 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Pfizer Investigational Site | Great Neck | New York | 11023 | United States |
| Pfizer Investigational Site | New York | New York | 10022 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28204 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27607 | United States |
| Pfizer Investigational Site | Fargo | North Dakota | 58103 | United States |
| Pfizer Investigational Site | Centerville | Ohio | 45459 | United States |
| Pfizer Investigational Site | Dayton | Ohio | 45432 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Pfizer Investigational Site | Medford | Oregon | 97504 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97210 | United States |
| Pfizer Investigational Site | Altoona | Pennsylvania | 16602 | United States |
| Pfizer Investigational Site | Levittown | Pennsylvania | 19056 | United States |
| Pfizer Investigational Site | Yardley | Pennsylvania | 19067 | United States |
| Pfizer Investigational Site | Cranston | Rhode Island | 02920 | United States |
| Pfizer Investigational Site | Huntingdon | Tennessee | 38344 | United States |
| Pfizer Investigational Site | Austin | Texas | 78705 | United States |
| Pfizer Investigational Site | Beaumont | Texas | 77701 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75234 | United States |
| Pfizer Investigational Site | Houston | Texas | 77074 | United States |
| Pfizer Investigational Site | Hurst | Texas | 76054 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78215 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84106 | United States |
| Pfizer Investigational Site | Christiansburg | Virginia | 24073 | United States |
| Pfizer Investigational Site | Bellevue | Washington | 98007 | United States |
| Pfizer Investigational Site | Broadmeadow | New South Wales | 2292 | Australia |
| Pfizer Investigational Site | Edmonton | Alberta | T5A 4L8 | Canada |
| Pfizer Investigational Site | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Pfizer Investigational Site | Vancouver | British Columbia | V5Z 1K3 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R2V 4W3 | Canada |
| Pfizer Investigational Site | Mount Pearl | Newfoundland and Labrador | A1N 5B6 | Canada |
| Pfizer Investigational Site | Dartmouth | Nova Scotia | B2Y 1H3 | Canada |
| Pfizer Investigational Site | Hamilton | Ontario | L8M 1K7 | Canada |
| Pfizer Investigational Site | London | Ontario | N5Y 5K7 | Canada |
| Pfizer Investigational Site | Oshawa | Ontario | L1H 7K4 | Canada |
| Pfizer Investigational Site | Sarnia | Ontario | N7T 4X3 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| Pfizer Investigational Site | Mirabel | Quebec | J7J 2K8 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G2B 5S1 | Canada |
| Pfizer Investigational Site | Saint Romuald | Quebec | G6W 5M6 | Canada |
| Pfizer Investigational Site | Sainte-Foy | Quebec | G1W 4R4 | Canada |
| Pfizer Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Pfizer Investigational Site | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Pfizer Investigational Site | Barranquilla | Atlántico | Colombia |
| Pfizer Investigational Site | Bogota | Cundinamarca | Colombia |
| Pfizer Investigational Site | Suwon | Kyonggi-do | 443-721 | South Korea |
| Pfizer Investigational Site | Seoul | Seoul/Korea | 138-736 | South Korea |
| Pfizer Investigational Site | Seoul | 120-752 | South Korea |
| Pfizer Investigational Site | Seoul | 137-701 | South Korea |
| Pfizer Investigational Site | Badalona | Barcelona/Spain | 08916 | Spain |
| Pfizer Investigational Site | Madrid | Madrid/Spain | 28006 | Spain |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MOA-728 12 mg QD | Participants received MOA-728 12 mg SC QD for 48 weeks. Dosing could be adjusted to PRN basis with a minimum 1 dose per week and maximum 1 dose per day. |
| 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 |
|
| 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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as an AE that emerged during the treatment period. Any TEAEs included both treatment-emergent SAEs and non-serious AEs. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Week 50 |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up | Weekly BM rate was derived as the total number of BMs reported in a month divided by the total number of days with non-missing BM diary information in the same month, then multiplied by 7 to normalize to a weekly rate. If the total number of days with non-missing BM diary information in a given month was less than 10 days, the weekly BM rate for the month was defined as missing. The weekly BM rate at baseline was calculated based on the screening period (Days -14 to -1). If the total number of days with non-missing BM diary information during the screening period was less than 5 days, the weekly BM rate at baseline was defined as missing. | All participants who received at least one dose of study drug. Here, 'Number analyzed' signifies participants evaluable at specified timepoint. | Posted | Mean | Standard Deviation | BM/week | Baseline, follow-up (14 days [Week 49 to 50]) |
|
|
Baseline up to Week 50
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MOA-728 12 mg QD | Participants received MOA-728 12 mg SC QD for 48 weeks. Dosing could be adjusted to PRN basis with a minimum 1 dose per week and maximum 1 dose per day. | 104 | 1,034 | 564 | 1,034 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Choroiditis | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lumbar hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oesophageal dilatation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abasia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Polyarteritis nodosa | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Perihepatic abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Traumatic liver injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Nuclear magnetic resonance imaging abnormal | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intentional drug misuse | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Granuloma skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Shoulder arthroplasty | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
Please contact Sponsor directly for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Bausch Health Americas, Inc | Lindsey.Mathew@bauschhealth.com |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
Not provided
Not provided
Not provided
|