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: 2025-12-25 @ 4:05 AM
Ignite Modification Date: 2025-12-26 @ 3:01 AM
NCT ID: NCT03539302
Description: The study collected adverse events of special interest which included events related to the device, pregnancy, AEs known to other formulations of flecainide, hypotension (BP \< 90/60 mmHg ), ventricular tachycardia (≥ 3 beats), Bradycardia (rate \< 50 bpm for ≥ 1 minute), Sinus pauses post conversion of AF to SR: an ECG-derived pause \> 3 seconds, Atrial flutter with 1:1 conduction with fast ventricular response (ventricular heart rate ≥ 200 bpm)
Frequency Threshold: 5
Time Frame: Adverse events were collected from the time of consent through Day 5.
Study: NCT03539302
Study Brief: INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part A 30 mg Dose Using FlecIH-102 30 mg dose using FlecIH-102 for acute cardioversion of AF to SR 0 None 0 10 9 10 View
Part A 60 mg Dose Using FlecIH-102 60 mg dose using FlecIH-102 for acute cardioversion of AF to SR 0 None 3 22 16 22 View
Part A 90 mg Dose Using FlecIH-102 90 mg dose using FlecIH-102 for acute cardioversion of AF to SR 0 None 1 21 17 21 View
Part A 120 mg Dose Using FlecIH-102 120 mg dose using FlecIH-102 for acute cardioversion of AF to SR 0 None 1 19 16 19 View
Part A 120 mg Dose Using FlecIH-103 120 mg dose using FlecIH-103 for acute cardioversion of AF to SR 0 None 2 29 25 29 View
Part B 120 mg Dose Using FlecIH-103 Dose confirmation cohort for 120 mg dose group using the final formulation of study drug, FlecIH-103. 0 None 2 25 17 25 View
Part C 120 mg Dose Using FlecIH-103 Dose expansion cohort for 120 mg dose using the final formulation of study drug, FlecIH-103. 0 None 0 44 23 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sinus arrest/Ventricular systole (asystolic pause) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Atrial flutter with 1:1 AV conduction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Sinus node dysfuntion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 23 & 23.1 View
Atrial fibrillation (hospitalization for recurrence of AF) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial Flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Salivary Hypersecretion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Oropharyngeal discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Atrial tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Cardiac flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v. 23 & 23.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 23 & 23.1 View
Oxygen saturation abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v. 23 & 23.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 23 & 23.1 View
Hyperventilation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Pharyngeal paraesthesia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Pharyngeal swelling NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v. 23 & 23.1 View
Blood pressure fluctuation NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v. 23 & 23.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v. 23 & 23.1 View
Sinus node dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 23 & 23.1 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 23 & 23.1 View
Condition aggravated NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 23 & 23.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 23 & 23.1 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 23 & 23.1 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 23 & 23.1 View
Sensation of foreign body NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 23 & 23.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v. 23 & 23.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 23 & 23.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v. 23 & 23.1 View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Throat tightness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Sinus arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
SV extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
SV tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 23 & 23.1 View
Odynophagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 23 & 23.1 View
Sinus Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Ventricular Systole NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v. 23 & 23.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 23 & 23.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v. 23 & 23.1 View
Chest Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v. 23 & 23.1 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v. 23 & 23.1 View
Dry Throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View
Respiratory Tract Irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v. 23 & 23.1 View