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: 2025-12-26 @ 10:34 AM
Ignite Modification Date: 2025-12-26 @ 10:34 AM
NCT ID: NCT03721328
Description: None
Frequency Threshold: 5
Time Frame: 12 Months
Study: NCT03721328
Study Brief: Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Local Irrigation With Vancomycin + Tobramycin Joint irrigation with vancomycin and tobramycin vancomycin hydrochloride and tobramycin sulfate: vancomycin hydrochloride and tobramycin sulfate via local irrigation 0 None 7 15 14 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rotavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Avulsion fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Device loosening SYSTEMATIC_ASSESSMENT Product Issues None View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haemorrhagic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cor pulmonale SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Arthritis infective SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stitch abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anaemia postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bone contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Burns second degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural haematuria SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fungal test positive SYSTEMATIC_ASSESSMENT Investigations None View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint warmth SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fibroadenoma of breast SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea 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
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Catheter placement SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Endodontic procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Wound drainage SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View