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 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:18 PM
NCT ID: NCT04396756
Description: All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
Study: NCT04396756
Study Brief: Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PLN-74809 (Part A) - 40 mg PLN-74809 (Part A) - 40 mg PLN-74809 0 None 0 1 1 1 View
PLN-74809 (Part B) - 40 mg PLN-74809 (Part B) - 40 mg PLN-74809 0 None 1 22 8 22 View
PLN-74809 (Part C) - 80 mg PLN-74809 (Part C) - 80 mg PLN-74809 0 None 0 23 8 23 View
PLN-74809 (Part C) -160 mg PLN-74809 (Part C) -160 mg PLN-74809 0 None 2 22 10 22 View
PLN-74809 (Part D) - 320 mg PLN-74809 (Part D) - 320 mg PLN-74809 1 None 2 22 18 22 View
Placebo Placebo Placebo 0 None 3 31 14 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bladder dilatation SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Idiopathic pulmonary fibrosis/Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acute left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Haemorrhagic arteriovenous malformation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyperlactacidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Idiopathic pulmonary fibrosis/Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations None View