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 @ 2:19 AM
Ignite Modification Date: 2025-12-26 @ 12:49 AM
NCT ID: NCT02250534
Description: None
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT02250534
Study Brief: Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.8 mg Nicotine 0.8 mg nicotine very low nicotine content cigarettes Very low nicotine content cigarettes 0 None 13 254 241 254 View
0.12 mg Nicotine 0.12 mg nicotine very low nicotine content cigarettes Very low nicotine content cigarettes 1 None 4 235 203 235 View
0.03 mg Nicotine 0.03 mg nicotine very low nicotine content cigarettes Very low nicotine content cigarettes 1 None 13 286 226 286 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sudden onset of chest pain due to not enough blood going to the heart SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (5.0) View
Bloody Stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Broken bone SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (5.0) View
Frontal lobe lesion SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Diabetes Type 2 SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Tenosynovitis of Hand SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Anxiety, feelings of dread or danger SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (5.0) View
Acute Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (5.0) View
Skin graft to wound on leg SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Neurosurgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (5.0) View
High blood pressure SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
General disorders SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Musculoskeletal and connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Injury, poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (5.0) View
Respiratory, thoracic and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Nervous system disorders SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Surgical and medical procedures SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (5.0) View