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 @ 12:38 PM
Ignite Modification Date: 2025-12-25 @ 12:12 PM
NCT ID: NCT02867761
Description: None
Frequency Threshold: 5
Time Frame: During the trial, approximately 12 weeks.
Study: NCT02867761
Study Brief: RETHINC: REdefining THerapy In Early COPD 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
Indacaterol/Glycopyrrolate indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily for 12 weeks Indacaterol/Glycopyrrolate: 27.5/15.6 mcg active indacaterol/glycopyrrolate 0 None 4 261 0 261 View
Placebo Placebo 27.5/15.6 mcg inhaled twice daily for 12 weeks Placebo: 27.5/15.6 mcg placebo 0 None 8 274 0 274 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Motor Vehicle Accident SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Breakthrough Seizures SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Gastric GJ junction ulcer and posterior wall perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Postprocedural Intraabdominal Abscess SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sigmoid diverticulitis with small abscess SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Respiratory Exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Uncontrolled hypertension SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vitamin B12 Deficiency SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Portal Hypertension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Community Acquired Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Kidney stone with obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anastomotic Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute Cholecystitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-displaced Fibular Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):