Adverse Events Module

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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 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:36 AM
NCT ID: NCT01302860
Description: None
Frequency Threshold: 0
Time Frame: Serious Adverse Events are monitored from date of First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), for up to 4 years. All other adverse events are monitored from First Participant First Treatment until LPLV, for up to 4 years.
Study: NCT01302860
Study Brief: Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Canakinumab Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks. None None 4 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cryopyrin associated periodic syndrome SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Cryptorchism SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Wound infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cryopyrin associated periodic syndrome SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Conductive deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Iridocyclitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Papilloedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eczema infected SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Enterobiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Molluscum contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
CSF white blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Motor developmental delay SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Speech disorder developmental SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hearing aid therapy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View