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: 2025-12-24 @ 2:22 PM
Ignite Modification Date: 2025-12-25 @ 12:58 PM
NCT ID: NCT00534495
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00534495
Study Brief: Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rilonacept Week (0-4) Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study Rilonacept: 2.2 mg/kg subcutaneously None None 1 36 9 36 View
Placebo Week (0-4) Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study Rilonacept: 2.2 mg/kg subcutaneously None None 1 35 19 35 View
Rilonacept Week (4-24) Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study Rilonacept: 2.2 mg/kg subcutaneously None None 3 35 27 35 View
Placebo Week (4-24) Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study Rilonacept: 2.2 mg/kg subcutaneously None None 1 33 28 33 View
Long Term Extension 24 Weeks to 21 Months None None None 6 40 28 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Juvenile Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abnormal Liver Function Test SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Variccela SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral uper respiratory tract infestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Mental status Changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pharingitis,Streptoccocal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastroenteritis ,Salmonela SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Histiocytosis,hematophagic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash SYSTEMATIC_ASSESSMENT Immune system disorders None View
Upper Respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations None View
Urinary tract infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Non Cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Rhinorea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Blood fibrinogen dicreased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine amino transferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate Amino transferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Abdominal pain ,upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pharyngitis,Streptococcal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View