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 @ 7:11 PM
Ignite Modification Date:
2025-12-25 @ 4:46 PM
NCT ID:
NCT03999203
Description:
None
Frequency Threshold:
0
Time Frame:
1 year, 11 months
Study:
NCT03999203
Study Brief:
A Cross-sectional Study to Measure Cough in Severe Asthma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| A - T2 High Severe Asthmatics | Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL and consistently high FeNO levels ≥20 ppb. Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu) | 0 | None | 0 | 22 | 0 | 22 | View |
| B - T2 Low Severe Asthmatics | Severe asthmatic patients with consistent eosinophil count ≤ 0.15x10\^9/mL and consistently low FeNO levels \<20 ppb. Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu) | 0 | None | 0 | 6 | 0 | 6 | View |
| C - Mild/Moderate Asthmatics | mild/moderate severe asthmatics (defined as step 2/3 using the GINA classification of severity) recruited from general respiratory clinics in the Belfast HSC Trust Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu) | 0 | None | 0 | 19 | 0 | 19 | View |
| D - T2 Intermediate | Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL OR consistently high FeNO levels ≥20 ppb. Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu) | 0 | None | 0 | 14 | 0 | 14 | View |
Serious Events(If Any):
Other Events(If Any):