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 @ 10:33 PM
Ignite Modification Date: 2025-12-25 @ 8:05 PM
NCT ID: NCT01726335
Description: Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
Frequency Threshold: 0
Time Frame: Baseline up to Week 50
Study: NCT01726335
Study Brief: Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants 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
Risperidone Prolonged Release Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3. None None 3 53 40 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Psychomotor hyperactivity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperprolactinaemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Salivary hypersecretion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Feeling jittery NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood prolactin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Orgasm abnormal NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Schizophrenia, disorganised type 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
Application site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood thyroid stimulating hormone increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypertriglyceridaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Increased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dystonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Extrapyramidal disorder 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
Abnormal behaviour NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Apathy NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Fear NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hostility NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Libido decreased NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Breast pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Erectile dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Galactorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View