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: 2025-12-26 @ 2:39 PM
Ignite Modification Date: 2025-12-26 @ 2:39 PM
NCT ID: NCT02593006
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events were collected from Baseline through Study completion. For each participant, the time period was on average 1 year
Study: NCT02593006
Study Brief: Start Time Optimization of Biologics in Polyarticular JIA
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Step-Up CTP Initial therapy with a non biologic Disease Modifying Anti-Rheumatic Drug (DMARD) stepping up to a biologic treatment if needed 0 None 12 257 19 257 View
Early Combination CTP Initial therapy with a non-biologic DMARD and biologic treatment at the start of treatment 0 None 3 100 5 100 View
Biologic First CTP Initial therapy with a biologic treatment without a non-biologic DMARD 0 None 5 43 1 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hip Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 21.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 21.0 View
Cervical Spine Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 21.0 View
Compund Fracture Ulna & Radius SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 21.0 View
Depression with Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA 21.0 View
Influenza SYSTEMATIC_ASSESSMENT General disorders MeDRA 21.0 View
Infections treated with IV antibiotics SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 21.0 View
Inflammatory Bowel Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 21.0 View
Drug induced Lupus SYSTEMATIC_ASSESSMENT Immune system disorders MeDRA 21.0 View
hip effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA 21.0 View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 21.0 View
Vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 21.0 View
Worsening Bipolar Affective Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA 21.0 View
Macrophage Activation Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MeDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MeDRA 21.0 View
Hypersensitivity Reaction SYSTEMATIC_ASSESSMENT Immune system disorders MeDRA 21.0 View
Inflammatory Bowel Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 21.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MeDRA 21.0 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 21.0 View
Uveitis (New Onset) SYSTEMATIC_ASSESSMENT Eye disorders MeDRA 21.0 View