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 @ 10:34 PM
Ignite Modification Date: 2025-12-25 @ 8:06 PM
NCT ID: NCT00760435
Description: None
Frequency Threshold: 0
Time Frame: 10 weeks
Study: NCT00760435
Study Brief: Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki 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
Infliximab Arm 98 recieved infliximab plus IVIG Infliximab: 5 mg/kg IV over 2 hours once None None 22 98 49 98 View
Placebo Arm 98 received Placebo plus IVIG Placebo: Placebo (same volume as active drug) None None 17 98 61 98 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fever None Immune system disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Coronary artery abnormality None Cardiac disorders None View
Anemia None Blood and lymphatic system disorders None View
Macrophage Activation Syndrome None Immune system disorders None View
Burn None Skin and subcutaneous tissue disorders None View
Headache None Nervous system disorders None View
URI None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
IVIG Infusion Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Coronary artery abnormality None Cardiac disorders None View
Rash None Skin and subcutaneous tissue disorders None View
URI None Infections and infestations None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Vomiting/nausea/abdominal pain None Gastrointestinal disorders None View
Worsening of WBC None Blood and lymphatic system disorders None View