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 @ 3:35 PM
Ignite Modification Date: 2025-12-25 @ 1:47 PM
NCT ID: NCT02227992
Description: The safety analysis set consists of all participants who received treatment.
Frequency Threshold: 0
Time Frame: Up to 44 days post-surgery on Day 0
Study: NCT02227992
Study Brief: The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EVARREST Sealant Matrix Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). 0 None 4 20 18 20 View
SURGICEL Absorbable Hemostat (Control) Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. 0 None 5 20 17 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Neuroblastoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Intussusception SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Localised intraabdominal fluid collection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Bloody Discharge SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Puncture site discharge SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Procedural hypotention SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Wound secretion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Blood alkaline phosphate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
International normalized ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Horner's syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Vulval oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Bradypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Device occlusion NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 16.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Dermatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Joint instability SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Anal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Gastroenteritis norovirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View