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 @ 11:15 PM
Ignite Modification Date: 2025-12-25 @ 8:52 PM
NCT ID: NCT01954056
Description: None
Frequency Threshold: 0.00
Time Frame: 10 days
Study: NCT01954056
Study Brief: Hydrocortisone for Term Hypotension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hydrocortisone hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose 0 None 1 6 0 6 View
Placebo Saline placebo Placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose 0 None 0 6 1 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
HYPERBILIRUBINEMIA REQUIRING EXCHANGE TRANSFUSION SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
HYPERTENSION, NEW AND SUSTAINED SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ADRENAL INSUFFICIENCY SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ATRIAL TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View