Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:45 AM
Ignite Modification Date: 2025-12-25 @ 10:58 PM
NCT ID: NCT03915067
Description: All-cause mortality: All participants randomized on Day 1. Serious and non-serious adverse events: Safety population included all participants who were administered study intervention.
Frequency Threshold: 5
Time Frame: All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.
Study: NCT03915067
Study Brief: BOTOX® for the Treatment of Platysma Prominence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1. 0 None 0 56 10 56 View
BOTOX® High Dose Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. 0 None 0 54 8 54 View
BOTOX® Low Dose Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. 0 None 2 59 6 59 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
THROMBOCYTOSIS SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
INJECTION SITE BRUISING SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
INJECTION SITE HAEMORRHAGE SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View