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 @ 9:42 PM
Ignite Modification Date: 2025-12-25 @ 7:23 PM
NCT ID: NCT02079532
Description: Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Frequency Threshold: 5
Time Frame: From first dose of study drug up to 24 weeks of follow up.
Study: NCT02079532
Study Brief: A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rituximab + MTX Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion. None None 36 302 62 302 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Musculoskeletal and connective tissue disorders NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Infections and infestations NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Injury, poisoning and procedural complications NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Gastrointestinal disorders NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Cardiac disorders NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
General disorders and administration site conditions NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Nervous system disorders NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Ear and labyrinth disorders NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.0 View
Endocrine disorders NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
Immune system disorders NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.0 View
Investigations NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Metabolism and nutrition disorders NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Psychiatric disorders NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Renal and urinary disorders NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Reproductive system and breast disorders NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Skin and subcutaneous tissue disorders NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Vascular disorders NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View