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 @ 3:46 AM
Ignite Modification Date: 2025-12-26 @ 2:33 AM
NCT ID: NCT00254202
Description: The safety analysis included patients who received 1 or more doses of study medication and 1 or more subsequent safety evaluations. To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.
Frequency Threshold: 5
Time Frame: None
Study: NCT00254202
Study Brief: Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute 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
Iloperidone Oral iloperidone 0 None 2 300 221 300 View
Ziprasidone Oral ziprasidone 0 None 2 150 118 150 View
Placebo Oral placebo 0 None 5 147 86 147 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Microcytic anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Weight increased SYSTEMATIC_ASSESSMENT Investigations None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View