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 @ 4:17 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT00432666
Description: The table of "Other Adverse Events" includes all AEs, both non serious and serious. Only results and AEs of the Double-Blind Period are given as the Open-Label Extension Period was a non-controlled study. The investigator asked the patient for AEs systematically at each visit.
Frequency Threshold: 2
Time Frame: All SAEs/AEs during Double-Blind Period After Injection.
Study: NCT00432666
Study Brief: IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
incobotulinumtoxinA (Xeomin) incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection None None 4 73 10 73 View
Placebo Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection None None 1 75 5 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchitis chronic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (9.1) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.1) View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (9.1) View
Intracranial haematoma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (9.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (9.1) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (9.1) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (9.1) View