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 @ 4:11 AM
Ignite Modification Date: 2025-12-26 @ 3:09 AM
NCT ID: NCT00493220
Description: Infusion site reaction assessments performed at baseline (shortly before study drug administration) and at 5, 30 and 45 minutes, and 1, 4, 6, 24, 36 and 48 hours after completion of study drug administration. Other adverse events were to be recorded whenever reported by the participant or observed by study staff.
Frequency Threshold: 5
Time Frame: from time of start of intervention administration through 7 days after intervention administered
Study: NCT00493220
Study Brief: Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HYLENEX SC All participants administered subcutaneous HYLENEX and ceftriaxone None None 0 30 30 30 View
Placebo SC All participants administered subcutaneous placebo and ceftriaxone None None 0 30 30 30 View
Intravenous All participants administered intravenous ceftriaxone None None 0 29 22 29 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infusion site anaesthesia SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
Infusion site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
Infusion site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
Infusion site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
Infusion site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
Infusion site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
Infusion site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
Vessel puncture site bruise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View