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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:44 PM
NCT ID: NCT01489969
Description: None
Frequency Threshold: 2
Time Frame: 28 days
Study: NCT01489969
Study Brief: Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Neu-P11 20mg Neu-P11 dose of 20 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment 0 None 0 45 8 45 View
Neu-P11 50mg Neu-P11 dose of 50 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment 0 None 0 47 3 47 View
Placebo matching placebo Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment 0 None 0 45 0 45 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Scarlet fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View