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: 2025-12-26 @ 1:19 PM
Ignite Modification Date: 2025-12-26 @ 1:19 PM
NCT ID: NCT03865706
Description: Due to the severity of illness in this population (ICU patients with sepsis), only pre-specified adverse events of interest and unanticipated problems that meet the definition of a serious adverse event were collected.
Frequency Threshold: 0
Time Frame: Up to Day 90
Study: NCT03865706
Study Brief: Inulin for Infections in the Intensive Care Unit
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Critically ill adults who are receiving broad-spectrum antibiotics will also receive placebo oral suspension for a minimum of 7 days. Placebo Oral Suspension: 250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor Broad-spectrum antibiotics: Standard of care treatment for infections 7 None 0 30 15 30 View
Inulin 16 g/Day Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (8g twice daily) for a minimum of 7 days. Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube Broad-spectrum antibiotics: Standard of care treatment for infections 7 None 0 30 11 30 View
Inulin 32 g/Day Critically ill adults who are receiving broad-spectrum antibiotics will also receive inulin oral suspension (16g twice daily) for a minimum of 7 days. Inulin Oral Suspension: Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube Broad-spectrum antibiotics: Standard of care treatment for infections 9 None 0 30 15 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Culture Proven Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View