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 @ 10:17 PM
Ignite Modification Date: 2025-12-26 @ 10:17 PM
NCT ID: NCT00283712
Description: All Adverse Events are included due to low sample size (20 participants).
Frequency Threshold: 5
Time Frame: None
Study: NCT00283712
Study Brief: Use of Infliximab for the Treatment of Pemphigus Vulgaris
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Infliximab Subjects randomized to the Infliximab group None None 1 10 9 10 View
Placebo Subjects randomized to the Placebo group None None 2 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Laryngeal obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pemphigus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pitting oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Staphylococcal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Vulval abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Back injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Sunburn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Monocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Metatarsalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Hallucination, olfactory SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Vulvovaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Exfoliative rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Heat rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Pemphigus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Skin erosion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View