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 @ 12:05 AM
Ignite Modification Date: 2025-12-25 @ 10:03 PM
NCT ID: NCT00592358
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00592358
Study Brief: Invega (Paliperidone) for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Paliperidone Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance. None None 0 15 14 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weight gain NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Worsening of anxiety and depressive symptoms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Low appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Strep throat NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Plaque-like skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Superficial scratches on arm NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Enuresis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Mild extrapyrimidal symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cold symptoms NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heart palpitation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seasonal allergies NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eye twitching NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Flu like symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View