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 @ 9:41 PM
Ignite Modification Date: 2025-12-25 @ 7:23 PM
NCT ID: NCT05025332
Description: None
Frequency Threshold: 5
Time Frame: 15 weeks for each participant starting on the day of first dosing
Study: NCT05025332
Study Brief: An Open-Label Study of Oral NNZ-2591 in Pitt Hopkins Syndrome (PTHS-001)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NNZ-2591 All enrolled participants who received at least one dose of IMP 0 None 0 16 15 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Ear Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Breath Odour SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Faeces Hard SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Intentional Self Injury SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Sleep Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Refraction Disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Pyelocaliectasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Gastroenteritis - viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Covid-10 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Otitis Media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Tongue Dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Arthropod Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Middle Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View