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 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:38 AM
NCT ID: NCT01189760
Description: The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
Frequency Threshold: 5
Time Frame: None
Study: NCT01189760
Study Brief: Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown 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
onabotulinumtoxinA 44U 44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. None None 5 305 58 305 View
onabotulinumtoxinA 24U 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. None None 8 306 51 306 View
Placebo (Normal Saline) Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. None None 6 306 38 306 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 14.0 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Uterine prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.0 View
Rectocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Breast cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View