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 @ 1:03 PM
Ignite Modification Date: 2025-12-25 @ 12:20 PM
NCT ID: NCT00636961
Description: The safety analysis set that consisted of all patients who received study medication and had at least one assessment.
Frequency Threshold: 3
Time Frame: None
Study: NCT00636961
Study Brief: An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study. None None 0 26 9 26 View
Indacaterol 300ug Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study. None None 0 26 9 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.X View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.X View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Tongue coated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.X View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Electrocardiogram ST segment depression SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Osteitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 10.X View