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 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:10 AM
NCT ID: NCT04370834
Description: One patient was enrolled to this trial. This patient enrolled to Cohort A1.
Frequency Threshold: 0
Time Frame: 30 days after tocilizumab administration
Study: NCT04370834
Study Brief: Tocilizumab for Patients With Cancer and COVID-19 Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A2 Clinical Status Ordinal Scale 3-4, Not on mechanical ventilation at time of registration and no immediate plan for intubation, Less than 30 kg 0 None 0 0 0 0 View
Cohort B1 Clinical Status Ordinal Scale 5-6, On mechanical ventilation at time of enrollment or imminent intubation indicated, At least 30 kg 0 None 0 0 0 0 View
Cohort B2 Clinical Status Ordinal Scale 5-6, On mechanical ventilation at time of enrollment or imminent intubation indicated, Less than 30 kg 0 None 0 0 0 0 View
Cohort A1 Clinical Status Ordinal Scale 3-4, Not on mechanical ventilation at time of registration and no immediate plan for intubation, At least 30 kg 1 None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE Version 5.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE Version 5.0 View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 5.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 5.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 5.0 View