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: 2025-12-25 @ 4:04 AM
Ignite Modification Date: 2025-12-26 @ 2:58 AM
NCT ID: NCT00424502
Description: None
Frequency Threshold: 0
Time Frame: Adverse events (AEs) and serious AEs (SAEs) were reported up to Week 48.
Study: NCT00424502
Study Brief: A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.
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 1000 mg Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14. None None 0 20 9 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Progression of rheumatoid arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Haemorrhagic suffusion NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Acute conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Infusion site pruritus NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Infusion site swelling NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Mood change NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Blood in stool NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Throat pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Dry eye sensation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Feeling of weakness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sleep disturbance NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Leucopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View