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 @ 2:20 AM
Ignite Modification Date: 2025-12-26 @ 12:51 AM
NCT ID: NCT00473434
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00473434
Study Brief: An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia
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 Extended Release (ER) Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks None None 27 64 51 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA SOC View
Lethargy NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA SOC View
Encephalitis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Intentional overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA SOC View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA SOC View
Non-Hodgkin's lymphoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA SOC View
Dystonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
Extrapyramidal disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Hallucination, auditory NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Mental disorders NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Paranoia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Schizoaffective disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Schizophrenia exacerbated NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA SOC View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA SOC View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
Akathisia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA SOC View