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 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:31 PM
NCT ID: NCT06218251
Description: None
Frequency Threshold: 1
Time Frame: All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 182 days for BOTOX.
Study: NCT06218251
Study Brief: A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BOTOX Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1. 0 None 0 100 19 100 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
EAR PAIN SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.1 View
CONJUNCTIVAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.1 View
FACIAL DISCOMFORT SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
DYSPLASTIC NAEVUS SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
BROW PTOSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
LIGAMENT SPRAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View