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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:54 PM
NCT ID: NCT03429556
Description: Safety Population included all participants exposed to any amount of study drug.
Frequency Threshold: 0
Time Frame: Up to 31 days
Study: NCT03429556
Study Brief: Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty
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 (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery. 0 None 0 12 8 12 View
Botulinum Neurotoxin Serotype E Dose 1 Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery. 0 None 0 4 3 4 View
Botulinum Neurotoxin Serotype E Dose 2 Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery. 0 None 0 4 4 4 View
Botulinum Neurotoxin Serotype E Dose 3 Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery. 0 None 0 3 3 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations 19.1 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders 19.1 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 19.1 View
Food allergy SYSTEMATIC_ASSESSMENT Immune system disorders 19.1 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View