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 @ 4:13 AM
Ignite Modification Date: 2025-12-26 @ 3:12 AM
NCT ID: NCT02759120
Description: None
Frequency Threshold: 1
Time Frame: Thirty-five months
Study: NCT02759120
Study Brief: CleanUP IPF for the Pulmonary Trials Cooperative
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Antimicrobial Therapy Plus Standard of Care Co-trimoxazole OR doxycycline Antimicrobial therapy: Co-trimoxazole or Doxycycline: 160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight \< 50 kilograms or 100mg twice daily if weight \> 50 kilograms for up to 36 months 37 None 71 254 62 254 View
Standard of Care Standard of care for patients with IPF for comparison No Intervention: Standard of Care: Standard of care 37 None 65 259 23 259 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Idiopathic pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embollism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Respiratory, thoracic and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administrative site conditions SYSTEMATIC_ASSESSMENT General disorders None View
Metabolic and nutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal and connective tissue disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders None View
Injury, poisoning, and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Renal and urinary disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hepatobiliary disorders SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Neoplasm benign, malignant, and unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Endocrine disorders SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Immune system disorders SYSTEMATIC_ASSESSMENT Immune system disorders None View
Investigations SYSTEMATIC_ASSESSMENT Investigations None View
Product issues SYSTEMATIC_ASSESSMENT Product Issues None View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View