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 @ 2:13 PM
Ignite Modification Date: 2025-12-25 @ 12:52 PM
NCT ID: NCT00504595
Description: None
Frequency Threshold: 5
Time Frame: 18 Weeks (12 Week treatment period + 6 Week Follow-up period)
Study: NCT00504595
Study Brief: Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ACZ885 (Canakinumab): Healthy Volunteers Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1. None None 0 10 6 10 View
Placebo Comparator: Healthy Volunteers Healthy Volunteers who received placebo Intravenous (IV) at Day 1. None None 0 10 4 10 View
ACZ885 (Canakinumab): RA Patients Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43. None None 2 50 12 50 View
Placebo Comparator: RA Patients Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43. None None 0 10 8 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deafness Neurosensory SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Acute Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis Acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory Tract Infection Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hepatic Enzyme Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Iron Deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Rheumatoid Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View