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 @ 4:27 PM
Ignite Modification Date: 2025-12-25 @ 2:20 PM
NCT ID: NCT00280566
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00280566
Study Brief: Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Period 1 Open Label Ziprasidone 40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy. None None 15 None 362 None View
Placebo Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2 None None 2 None 24 None View
Ziprasidone Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period. None None 3 None 22 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 11.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Affect lability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bipolar I disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression suicidal SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychiatric decompensation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View