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 @ 1:12 AM
Ignite Modification Date: 2025-12-25 @ 11:23 PM
NCT ID: NCT01391793
Description: Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.
Frequency Threshold: 5
Time Frame: Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs.
Study: NCT01391793
Study Brief: Corticosteroids for Children With Febrile Urinary Tract Infections
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adjuvant Dexamethasone Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days 0 None 9 271 68 271 View
Placebo Placebo: Twice daily for 3 days 0 None 9 275 52 275 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NIH Toxicity Tables View
Dehydration SYSTEMATIC_ASSESSMENT General disorders NIH Toxicity Tables View
Fever unspecified SYSTEMATIC_ASSESSMENT General disorders NIH Toxicity Tables View
Fussy infant SYSTEMATIC_ASSESSMENT General disorders NIH Toxicity Tables View
Kawasaki's disease SYSTEMATIC_ASSESSMENT General disorders NIH Toxicity Tables View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations NIH Toxicity Tables View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations NIH Toxicity Tables View
Retropharyngeal abscess SYSTEMATIC_ASSESSMENT Infections and infestations NIH Toxicity Tables View
Poor weight gain in infact SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NIH Toxicity Tables View
Acute pyelonephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders NIH Toxicity Tables View
Posterior urethral values SYSTEMATIC_ASSESSMENT Renal and urinary disorders NIH Toxicity Tables View
Pyelonephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders NIH Toxicity Tables View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders NIH Toxicity Tables View
Rash; non-specific skin eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NIH Toxicity Tables View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NIH Toxicity Tables View
Fever SYSTEMATIC_ASSESSMENT General disorders NIH Toxicity Tables View
Fussiness SYSTEMATIC_ASSESSMENT General disorders NIH Toxicity Tables View
Urinary Tract Infection (UTI) symptoms SYSTEMATIC_ASSESSMENT Renal and urinary disorders NIH Toxicity Tables View