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 @ 6:30 PM
Ignite Modification Date: 2025-12-25 @ 4:00 PM
NCT ID: NCT03260868
Description: Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.
Frequency Threshold: 5
Time Frame: All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product.
Study: NCT03260868
Study Brief: Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Virtual Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data. 0 None 1 8 2 8 View
Traditional Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits. 0 None 1 6 4 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Obstructive Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Cholecystitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.1 View
Escherichia Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Loss Of Consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.1 View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Alcohol Poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Head Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Blood Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Intervertebral Disc Degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Vertebral Osteophyte SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Intermittent Claudication SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View