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 @ 7:36 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT01010503
Description: None
Frequency Threshold: 0
Time Frame: Serious adverse events (SAEs) related to study medication were reported irrespective of elapsed time from last administration of study medication. Non-related SAEs were reported during the study period and 28 days after the last dose of study medication.
Study: NCT01010503
Study Brief: A Study of Tocilizumab With or Without 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
Tocilizumab 8 mg/kg Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). None None 3 32 10 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Crash of left foot local infection of skin and subcutaneous tissue NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Lumbago NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Congestive heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hepatopathy SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (10.0) View
Leucopenia+lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
Acute bronchitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (10.0) View
Acute nasopharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Acute pulpitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View