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: 2025-12-25 @ 2:44 AM
Ignite Modification Date: 2025-12-26 @ 1:23 AM
NCT ID: NCT03208933
Description: None
Frequency Threshold: 5
Time Frame: Up to 52 Weeks
Study: NCT03208933
Study Brief: Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF).
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pirfenidone Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks 7 None 10 60 32 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Idiopathic pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 22.1 View
Bronchitis chronic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 22.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 22.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA version 22.1 View
Sudden cardiac death SYSTEMATIC_ASSESSMENT General disorders MedDRA version 22.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 22.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 22.1 View
Bronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 22.1 View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 22.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 22.1 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 22.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 22.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 22.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 22.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 22.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 22.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 22.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 22.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 22.1 View