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 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:18 AM
NCT ID: NCT04326920
Description: None
Frequency Threshold: 5
Time Frame: Timeframe for reporting adverse events: through study completion, an average of 5 months
Study: NCT04326920
Study Brief: Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Sargramostim Treatment Group Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment Sargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration 4 None 6 40 22 40 View
Control Group standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days Sargramostim: Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration Control: Standard of care 8 None 6 41 20 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ventilator associated pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Persistent catatonic state and neurological deficits NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Invasive aspergillosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Multi-bacterial bacteremia causing hemorrhagic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thormboembolic event NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aspergillus infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory deterioration due to underlying MPO-ANCA vasculitis and aspergillosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Infectious disorder (not COVID-19) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View