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 @ 5:12 PM
Ignite Modification Date: 2025-12-25 @ 2:50 PM
NCT ID: NCT01658150
Description: None
Frequency Threshold: 0
Time Frame: 4 weeks
Study: NCT01658150
Study Brief: Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Isradipine Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. isradipine as utilized in this trial will be administered twice daily. Isradipine will be titrated as follows: baseline (week 0) 5 mg/day BID; Week 2 increase to 10 mg/day BID if 5 mg was well-tolerated. Dosing will be flexible based on side effects with a maximum=10 mg/day. If 5 mg cannot be tolerated, the subject will be discontinued. 0 None 0 11 11 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Dizziness SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (10.0) View
Menstrual irregular SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (10.0) View
Difficulty sleeping SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Hypersomnia SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Poor concentration SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Restlessness SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Poor coordination SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Frequent urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (10.0) View
Loss of libido SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (10.0) View
Decreased energy SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View