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 @ 4:06 PM
Ignite Modification Date: 2025-12-25 @ 2:07 PM
NCT ID: NCT00748566
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 5
Time Frame: None
Study: NCT00748566
Study Brief: One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ziprasidone Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365. None None 20 172 122 172 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v15.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v15.0 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v15.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Hallucinations, mixed NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Malignant melanoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v15.0 View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v15.0 View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v15.0 View
Adjustment disorder with mixed anxiety and depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Attention-seeking behaviour NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v15.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v15.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v15.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v15.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v15.0 View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v15.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v15.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v15.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v15.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v15.0 View