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 @ 12:31 PM
Ignite Modification Date: 2025-12-25 @ 12:09 PM
NCT ID: NCT06350461
Description: None
Frequency Threshold: 5
Time Frame: From randomization (Week 0) up to last study visit (Week 6), i.e., 6 weeks.
Study: NCT06350461
Study Brief: Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-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
HS-Discontinue Discontinuation of current hypertonic saline (HS) therapy Discontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period. 0 None 2 184 5 184 View
HS-Continue Continuation of current hypertonic saline (HS) therapy Continuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%. 0 None 1 186 10 186 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View
Infective pulmonary exacerbation of cystic fibrosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (23.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (23.0) View