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 @ 2:13 PM
Ignite Modification Date: 2025-12-25 @ 12:52 PM
NCT ID: NCT01437995
Description: Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
Frequency Threshold: 2
Time Frame: 52 weeks
Study: NCT01437995
Study Brief: Long-acting Beta Agonist Step Down Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stable ICS-LABA Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily None None 7 151 110 151 View
Reduced ICS/LABA Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily None None 3 149 102 149 View
LABA Step Off Fluticasone Diskus alone 250 ug twice daily without Salmeterol Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol None None 15 155 100 155 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stroke NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Partial small bowel obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hospitalized for contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Chest discomfort, shortness of breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute renal failure, resolved NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Elevated blood sugar NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Graves' Disease, diagnosis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Appendectomy NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Knee replacement (planned) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Asthma Exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Increased/irregular heartbeat SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Restlessness or nervousness SYSTEMATIC_ASSESSMENT General disorders None View
Runny nose/congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View