Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MNTX 12 mg | Experimental | Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant). |
|
| MNTX 24 mg | Experimental | Participants will receive MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant). |
|
| Placebo | Placebo Comparator | Participants will receive placebo matching to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylnaltrexone | Drug | Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Bowel Movement | Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred. | Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discharge Eligibility | Time to discharge eligibility was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Discharge eligibility was defined as both tolerance of solid food and at least one bowel movement. Participants were considered to have tolerated solid food when they have eaten greater than or equal to (≥) 50 percent (%), of the first of two successive solid food meals (based on the judgement of the investigator or designee), without vomiting or nausea. Participants readmitted to the hospital with a diagnosis of POI within 7 days of discharge were considered treatment failures. Analysis was performed by Kaplan-Meier estimate. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lindsey Mathew | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Progenics Pharmaceuticals | Tarrytown | New York | 10591 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21471758 | Derived | Yu CS, Chun HK, Stambler N, Carpenito J, Schulman S, Tzanis E, Randazzo B. Safety and efficacy of methylnaltrexone in shortening the duration of postoperative ileus following segmental colectomy: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2011 May;54(5):570-8. doi: 10.1007/DCR.0b013e3182092bde. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Postoperative participants (who underwent segmental colectomy via open laparotomy) were randomized in 1:1:1 ratio to MNTX 12 mg, MNTX 24 mg, or placebo treatment groups. Randomization was based on regional stratification.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MNTX 12 mg | Participants received methylnaltrexone (MNTX) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). |
| FG001 | MNTX 24 mg | Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). |
| FG002 | Placebo | Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MNTX 12 mg | Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time to First Bowel Movement | Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred. | mITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Mean | Standard Error | days | Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10 |
|
Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to end of follow-up visit (Day 17)
Safety population included all randomized participants who received at least 1 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 | MNTX 12 mg | Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Bausch Health Americas, Inc | Lindsey.Mathew@bauschhealth.com |
Not provided
| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arm. |
|
| Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10 |
| Time to Discharge Order Written From the End of Surgery | The investigator or designee recorded the time of the order. Participants re-admitted to the hospital with a diagnosis of POI within 7 days after discharge were considered treatment failures. Analysis was performed by Kaplan-Meier estimate. | Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10 |
| Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at 0 or 24 Hours as Evaluated by the Opioid-Related Symptom Distress Scale (SDS) | CMEs were defined using opioid-related SDS (assessed participant-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe (3) or very severe (4), with the exception of confusion. A total CME score was calculated by summing the number of CMEs across symptoms and ranged from 0 to 9. CME was counted for either nausea or vomiting/retching, or both and reported in this outcome measure. | 0 and 24 hours |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other than specified |
|
| Randomized but not treated |
|
| BG001 | MNTX 24 mg | Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). |
| BG002 | Placebo | Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received MNTX 12 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). |
| OG001 | MNTX 24 mg | Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). |
| OG002 | Placebo | Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). |
|
|
|
| Secondary | Time to Discharge Eligibility | Time to discharge eligibility was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Discharge eligibility was defined as both tolerance of solid food and at least one bowel movement. Participants were considered to have tolerated solid food when they have eaten greater than or equal to (≥) 50 percent (%), of the first of two successive solid food meals (based on the judgement of the investigator or designee), without vomiting or nausea. Participants readmitted to the hospital with a diagnosis of POI within 7 days of discharge were considered treatment failures. Analysis was performed by Kaplan-Meier estimate. | mITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Mean | Standard Error | days | Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10 |
|
|
|
| Secondary | Time to Discharge Order Written From the End of Surgery | The investigator or designee recorded the time of the order. Participants re-admitted to the hospital with a diagnosis of POI within 7 days after discharge were considered treatment failures. Analysis was performed by Kaplan-Meier estimate. | mITT population included all randomized participants who received at least 1 dose of study drug. | Posted | Mean | Standard Error | days | Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10 |
|
|
|
| Secondary | Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at 0 or 24 Hours as Evaluated by the Opioid-Related Symptom Distress Scale (SDS) | CMEs were defined using opioid-related SDS (assessed participant-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe (3) or very severe (4), with the exception of confusion. A total CME score was calculated by summing the number of CMEs across symptoms and ranged from 0 to 9. CME was counted for either nausea or vomiting/retching, or both and reported in this outcome measure. | mITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | 0 and 24 hours |
|
|
|
| 26 |
| 171 |
| 121 |
| 171 |
| EG001 | MNTX 24 mg | Participants received MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). | 33 | 173 | 124 | 173 |
| EG002 | Placebo | Participants received placebo matched to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurred: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug was administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). | 38 | 171 | 138 | 171 |
| Cardiac failure congestive | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal haematoma | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Colonic obstruction | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Colonic stenosis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pancreatic fistula | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Peritoneal effusion | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Thrombosis mesenteric vessel | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chronic gastrointestinal bleeding | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal sepsis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Haematoma infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Incision site cellulitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Incision site infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Pelvic abscess | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Failure to anastomose | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Post procedural pulmonary embolism | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Postoperative respiratory distress | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Postoperative thrombosis | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Hepatic enzyme abnormal | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| General nutrition disorder | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Colon cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
Please contact Sponsor directly for additional information.
| Title | Measurements |
|---|---|
|