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 @ 9:08 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT01683604
Description: None
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Study: NCT01683604
Study Brief: Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RA Participants (All Groups) Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months. None None 2 37 12 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mycoplasma infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (Unspecified) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (Unspecified) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View