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: NCT03506061
Description: None
Frequency Threshold: 5
Time Frame: Information about adverse events was collected from the time of consent through Day 56.
Study: NCT03506061
Study Brief: Trikafta in Cystic Fibrosis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Participants With Evidence of Partial Function (Sweat Chloride < 80 mEq/L or Pancreatic Sufficiency) Participants with cystic fibrosis (CF) with evidence of partial function (sweat chloride \< 80 milliequivalents per liter (mEq/L) or pancreatic sufficiency) receiving Trikafta for 28 days. 0 None 0 22 17 22 View
Participants Who Encode the N1303K Variant Participants with cystic fibrosis (CF) who encode the N1303K variant receiving Trikafta for 28 days. 0 None 1 20 14 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization due to cystic fibrosis pulmonary exacerbation caused by pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased coughing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Increased sputum production NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infective pulmonary exacerbation of cystic fibrosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Body aches NON_SYSTEMATIC_ASSESSMENT General disorders None View
Increased wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Testicular pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Joint pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eosinophilia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Decreased forced expiratory volume in one second (FEV1) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Coronavirus disease 2019 (COVID-19) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Increased anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Lower respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vision changes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View