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 @ 5:55 PM
Ignite Modification Date: 2025-12-25 @ 3:19 PM
NCT ID: NCT00545168
Description: Verbatim descriptions of AEs were assigned to system organ classes and preferred terms using the MedDRA dictionary (v10.1). All randomized subjects who were presumed to have used the study medication at least once and who provided at least one post-baseline evaluation or reported at least one AE subsequent to using the study medication.
Frequency Threshold: 1
Time Frame: Through out the study (7 months).
Study: NCT00545168
Study Brief: Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A/B - NatrOVA 1% - With/Without Nit Combing NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required None None 0 258 2 258 View
C - NIX Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use None None 1 211 16 211 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal Viral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View