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 @ 7:42 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT04073303
Description: None
Frequency Threshold: 5
Time Frame: All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time followed) was 539.0 and 540.0 Days for Placebo and BOTOX ®, respectively.
Study: NCT04073303
Study Brief: BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle 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 Placebo was administered as bilateral intramuscular injections into the masseter on Day 1 0 None 4 93 19 93 View
BOTOX® BOTOX ® was administered as bilateral intramuscular injections into the masseter on Day 1, with the possibility of 2 additional treatments 0 None 11 283 54 283 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
VENTRICULAR EXTRASYSTOLES SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
HAEMORRHOIDS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
GALLBLADDER POLYP SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
POST-ACUTE COVID-19 SYNDROME SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
PULMONARY TUBERCULOSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
POST HERPETIC NEURALGIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
ABORTION OF ECTOPIC PREGNANCY SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 25.1 View
ABORTION THREATENED SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 25.1 View
FOETAL GROWTH RESTRICTION SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 25.1 View
ENDOMETRIOSIS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25.1 View
FALLOPIAN TUBE CYST SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25.1 View
LUNG OPACITY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
NASAL SEPTUM DEVIATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
ABORTION INDUCED SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
MASTICATION DISORDER SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View