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 @ 5:09 PM
Ignite Modification Date: 2025-12-25 @ 2:47 PM
NCT ID: NCT04642950
Description: None
Frequency Threshold: 5
Time Frame: Day1-28
Study: NCT04642950
Study Brief: A Phase II/III Study of Sargramostim
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NPC-26 Sargramostim (125 μg) will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment. Sargramostim: 250 μg/vial of sargramostim will be dissolved in 4 mL of physiological saline and 125 μg of which will be administered using inhaler twice daily in approximately 10-15 minutes. 0 None 2 47 22 47 View
NP-26 Placebo Physiological saline will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment. Placebo: 2 mL of physiological saline will be administered using inhaler twice daily in approximately 10-15 minutes. 0 None 0 23 8 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA23.0 View
COVID-19 pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hepatocellular injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA23.0 View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA23.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA23.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA23.0 View
White blood cell count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA23.0 View