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 @ 11:36 PM
Ignite Modification Date: 2025-12-25 @ 9:26 PM
NCT ID: NCT00915356
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00915356
Study Brief: Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD1305 Dose Group 4 AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h. None None 1 None 3 12 View
AZD1305 Dose Group 1 AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h. None None 1 None 5 26 View
AZD1305 Dose Group 2 AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h. None None 3 None 9 45 View
AZD1305 Dose Group 3 AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h. None None 3 None 8 45 View
Placebo Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h. None None 2 None 5 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Multiple drug overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Cardiac asthma SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Abdominal wall haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Torsade de pointes SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Gastritis fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Sensation of heaviness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View