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: 2025-12-25 @ 2:02 AM
Ignite Modification Date: 2025-12-26 @ 12:27 AM
NCT ID: NCT03113760
Description: Day to day fluctuations of the underlying disease of interest or other pre-existing disease or conditions present or detected at the start of the study were not to be reported as separate adverse events but assessed via the modified autoinflammatory disease index (mAIDAI) at scheduled or unscheduled visits in case of a disease reactivation.
Frequency Threshold: 0
Time Frame: Adverse events were monitored and recorded for up to 34 weeks (from informed consent signature until completion of the study).
Study: NCT03113760
Study Brief: Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Randomized Withdrawal - Tadekinig Alfa Arm The Tadekinig alfa - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Tadekinig alfa in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase. 0 None 0 5 4 5 View
Single Arm Open-Label - Tadekinig Alfa The Single Arm Open-Label Full Analysis Set (SAOL-FAS) includes all patients treated with Tadekinig alfa in the first 18 weeks of treatment. 0 None 3 14 14 14 View
Randomized Double-Blind Placebo-Controlled - Placebo Arm The Randomized Double-Blind Placebo-Controlled (RDBPC) Analysis Set includes 1 patient treated with Placebo in the first treatment phase. 0 None 0 1 1 1 View
Randomized Withdrawal - Placebo Arm The Placebo - Randomized Withdrawal Full Analysis Set (RW-FAS) includes all patients who met the criteria for randomization and were randomized to blinded treatment with Placebo in the up to 16 weeks randomized withdrawal phase, which follows the SAOL phase. 0 None 0 5 4 5 View
Screening Phase Time from informed consent signature up to day prior to first dose of study treatment 0 None 1 15 7 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Coronary artery dilatation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Complication associated with device SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Secretion discharge SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Red blood cell sedimentation rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Adenovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Coronavirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Cytomegalovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Human rhinovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Interleukin-2 receptor increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Sapovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Serum ferritin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Vital signs measurement SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Fontanelle bulging SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 22 View
Ocular hypertension SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Inflammatory bowel disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Hepatosplenomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Macule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Palmar erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Synovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Epstein-Barr viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Tinea infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
External ear cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Groin abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View