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 @ 3:37 AM
Ignite Modification Date: 2025-12-26 @ 2:21 AM
NCT ID: NCT00761605
Description: Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
Frequency Threshold: 2
Time Frame: Baseline up to Week 24
Study: NCT00761605
Study Brief: Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants
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 Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day. None None 38 387 209 387 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intervertebral disc degeneration NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Psychiatric symptom NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hyperprolactinaemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Colon cancer stage IV NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastases to liver NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Acute psychosis NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Aggression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Completed suicide NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Delusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hallucination, auditory NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Panic attack NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cholecystectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Gastrectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperprolactinaemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Oculogyration NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Bradykinesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Extrapyramidal disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hallucination, auditory NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Amenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Muscle rigidity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View