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 @ 4:57 PM
Ignite Modification Date: 2025-12-25 @ 2:39 PM
NCT ID: NCT01866150
Description: Adverse events data were planned to be collected only for those participants who received rituximab or tocilizumab, as biologic therapy.
Frequency Threshold: 5
Time Frame: Baseline up to the last visit after initiation of first line biologic treatment (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Study: NCT01866150
Study Brief: A Retrospective, Observational Chart Review of Biologics in Monotherapy Versus the Combination Biologic Plus Methotrexate in Patients With 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
Biologic Monotherapy Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) as monotherapy according to NICE guidelines. None None 0 7 0 7 View
Biologic Combination Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines. None None 0 9 2 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Influenza Like Illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Ear Pruritus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 16.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Hot Flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View