Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 10:50 PM
Ignite Modification Date: 2025-12-25 @ 8:19 PM
NCT ID: NCT01046669
Description: Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Frequency Threshold: 5
Time Frame: Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment.
Study: NCT01046669
Study Brief: Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sham Standard medical care for septic shock 78 None 126 220 60 220 View
Treatment Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock. 84 None 140 212 56 212 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Heparin-induced thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cor pulmonale chronic SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulseless electrical activity SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Torsade de pointes SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Adrenal harmorrhage SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal compartment syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Duodenal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Obstructive gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophagal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophagal varices haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis necrotising SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Device leakage SYSTEMATIC_ASSESSMENT General disorders None View
Device malfunction SYSTEMATIC_ASSESSMENT General disorders None View
Disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Terminal state SYSTEMATIC_ASSESSMENT General disorders None View
Thrombosis in device SYSTEMATIC_ASSESSMENT General disorders None View
Acute hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cholecystitis chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Chronic hepatic failure SYSTEMATIC_ASSESSMENT General disorders None View
Cirrhosis alcoholic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatic infarction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Abdominal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abscess neck SYSTEMATIC_ASSESSMENT Infections and infestations None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Biliary sepsis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations None View
Necrotising fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Orchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Uninary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anaphylactic transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Brain herniation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diaphragmatic injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gastrointestinal anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gastrointestinal stoma complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Splenic injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound evisceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood lactic acid increased SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Chondrocalcinosis pyrophosphate SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Crystal arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Scleroderma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Soft tissue necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Adrenal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Benign neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Chloroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastatic squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Multiple myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Embolic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Eating disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mental status change SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Faecaluria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aspiration SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epitaxis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Purpura fulminans SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Steven-Johnson syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bleeding varicose vein SYSTEMATIC_ASSESSMENT Vascular disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Embolism venous SYSTEMATIC_ASSESSMENT Vascular disorders None View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infarction SYSTEMATIC_ASSESSMENT Vascular disorders None View
Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vascular insufficiency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Enterocutaneous fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cardiac Death SYSTEMATIC_ASSESSMENT General disorders None View
Hepatorenal syndrome SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Splenic abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Small cell lung cancer stage unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Brain injury SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Brain stem stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal failure chronic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View