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 @ 7:34 PM
Ignite Modification Date: 2025-12-25 @ 5:15 PM
NCT ID: NCT02233803
Description: Safety population comprised of all participants who received at least one dose of study treatment. This population was based on the treatment the participant actually received.
Frequency Threshold: 3
Time Frame: Up to 14 wks
Study: NCT02233803
Study Brief: A Non-inferiority Study to Evaluate Efficacy, Safety and Tolerability of NEUMOTEROL® 400 and SYMBICORT® Forte in Adults With 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
NEUMOTEROL 400 Eligible participants received NEUMOTEROL 400 during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication. 0 None 1 193 10 193 View
SYMBICORT FORTE Eligible participants received Symbicort forte during TP1 or TP2 as per their randomization. The TPs were separated by washout period of 4-wks during which participants received NEUMOTEX 400, twice daily. The participants were allowed to take salbutamol 100mcg pMDI, as rescue medication. 0 None 1 194 11 194 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View