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 @ 9:24 PM
Ignite Modification Date: 2025-12-25 @ 7:10 PM
NCT ID: NCT04578132
Description: Adverse events were only collected and reported in the subgroup of patients treated with immunotherapy (n=87) All cause mortality reported in the overall population
Frequency Threshold: 0
Time Frame: 2 year Note: Adverse events were only collected and reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection (n=87)
Study: NCT04578132
Study Brief: Description of the Population With Genitourinary Tumors and COVID-19
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adverse Events Adverse events reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection. The main scope of this trial was not safety. Therefore, the study did not record adverse events in patients treated with other therapies. The study did not record serious adverse events sistematically. This partial information about safety was the only information of adverse events collected during this observational study. 152 None 0 87 22 87 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (5.0) View
Nephritis SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (5.0) View
Colitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Arthritis SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (5.0) View