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 @ 9:30 PM
Ignite Modification Date: 2025-12-25 @ 7:15 PM
NCT ID: NCT03132532
Description: None
Frequency Threshold: 0
Time Frame: Up to 5 years
Study: NCT03132532
Study Brief: Platinum Doublet Chemotherapy and Proton Beam Radiation Therapy in Treating Patients With Stage II-III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT) Questionnaire Administration: Ancillary studies 6 None 5 10 10 10 View
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT) Questionnaire Administration: Ancillary studies 5 None 5 9 7 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Esophageal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View