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 @ 4:08 PM
Ignite Modification Date: 2025-12-25 @ 2:08 PM
NCT ID: NCT01252966
Description: Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
Frequency Threshold: 5
Time Frame: AE and SAE data were collected from enrollment through follow up (~31 weeks).
Study: NCT01252966
Study Brief: Cognitive Training for Nicotine Dependence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Training None None None 3 105 54 105 View
Cognitive Training None None None 6 108 42 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Squamous Cell Carcinoma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Emergency Procedure NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bowel Blockage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Collapsed Lung NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Breast Cancer NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Surgery (Gastric Bypass) NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Disturbing Dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Skin Irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View