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 @ 1:45 AM
Ignite Modification Date: 2025-12-26 @ 12:03 AM
NCT ID: NCT01797094
Description: The Safety Population, all enrolled participants who received study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
Frequency Threshold: 5
Time Frame: None
Study: NCT01797094
Study Brief: BOTOX® in the Treatment of Upper Facial Lines in Japan
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Botulinum Toxin Type A (32U) 32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. None None 4 53 22 53 View
Botulinum Toxin Type A (44U) 44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. None None 1 47 20 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatitis A SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Bartholin's cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 17.0 View
Benign female reproductive tract neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 17.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Eyelid ptosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 17.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View