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 @ 12:53 PM
Ignite Modification Date: 2025-12-25 @ 12:17 PM
NCT ID: NCT04343261
Description: Adverse event and/or serious adverse event related to treatment with convalescent plasma
Frequency Threshold: 1
Time Frame: Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).
Study: NCT04343261
Study Brief: Convalescent Plasma in the Treatment of 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
COVID-19 Patients Treated With Convalescent Plasma Severely ill COVID-19 patients treated with convalescent plasma Convalescent Plasma: treatment with 2 Units of convalescent plasma 22 None 8 48 8 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Persistent Hypoxemia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension; Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pneumothorax; subcutaneous emphysema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumatosis intestinalis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Insufficient Antibodies NON_SYSTEMATIC_ASSESSMENT Product Issues None View