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 @ 3:44 PM
Ignite Modification Date: 2025-12-25 @ 1:52 PM
NCT ID: NCT00761592
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00761592
Study Brief: Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Botulinum Toxin Type A 900kDa None None None 1 None 21 None View
Botulinum Toxin Type A 150kDa None None None 1 None 24 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Carotid Artery Stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Angioneurotic oedema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mastication Disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervousness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eyelid ptosis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eyelid oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Lid Lag NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Sicca Syndrome NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Salivary hypersecretion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eye Swelling NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Periorbital haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscle Spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular Weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View