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 @ 1:21 AM
Ignite Modification Date: 2025-12-25 @ 11:30 PM
NCT ID: NCT04702893
Description: Treated set (TS): All patients with signed informed consent who received at least one dose of nintedanib.
Frequency Threshold: 5
Time Frame: Adverse events and all-cause mortality: From first nintedanib administration to 52±6 weeks thereafter plus 28 days of residual effect period. Up to 62 weeks.
Study: NCT04702893
Study Brief: INREAL - Nintedanib for Changes in Dyspnea and Cough in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease (ILD) With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nintedanib-treated Patients Patients diagnosed with chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype (excluding idiopathic pulmonary fibrosis (IPF)), who did not receive previous antifibrotic treatment, received 150 milligrams (mg) of nintedanib twice daily, administered 12 hours apart, according to the approved label, for approximately 52 weeks. Participants who did not tolerate 150 mg of nintedanib switched to 100 mg twice daily. 10 None 16 102 45 102 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.1 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.1 View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.1 View
Nasal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Inflammatory marker increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.1 View
Hepatic cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.1 View
Skin squamous cell carcinoma metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.1 View
Prerenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.1 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.1 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.1 View