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 @ 9:06 PM
Ignite Modification Date: 2025-12-25 @ 6:57 PM
NCT ID: NCT00288704
Description: All serious adverse events were considered not related to receiving rilonacept by the physician at the site. Other adverse events were shown if a minimum of 2 subjects (approximately 4 percent of the Part A subjects) had the event during the 6-week, double-blind period.
Frequency Threshold: 4
Time Frame: Serious adverse events (SAEs) were reported for all phases (double blind, randomized withdrawal, and OLE) of the study. There were no SAEs for subjects on placebo during Parts A or B. Other adverse events were shown for the six week double-blind period.
Study: NCT00288704
Study Brief: Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo None None None 0 24 13 24 View
Rilonacept 160 mg None None None 7 104 17 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Renal Colic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Arteriosclerosis of the coronary artery NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Meningitis pneumococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (11.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 11.0 View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (11.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 11.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 11.0 View
Abdominal pain, upper abdomen NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Hypoesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Stomach Discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View