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 @ 10:44 PM
Ignite Modification Date: 2025-12-26 @ 10:44 PM
NCT ID: NCT01988012
Description: The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
Frequency Threshold: 5
Time Frame: Up to Follow-up Week 32
Study: NCT01988012
Study Brief: A Study of the Efficacy and Safety of Tocilizumab in Adults 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
Tocilizumab Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators' discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended. None None 6 100 44 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.1) View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Adnexal torsion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (18.1) View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.1) View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.1) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.1) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.1) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.1) View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.1) View