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 @ 1:33 PM
Ignite Modification Date: 2025-12-25 @ 12:33 PM
NCT ID: NCT01898195
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01898195
Study Brief: Improving Adherence to Smoking Cessation Medication Among PLWHA
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Care Participants in this arm will receive varenicline for smoking cessation. Varenicline: Varenicline will be provided for three months. None None 0 53 9 53 View
Standard Care + Text Message Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts. Varenicline: Varenicline will be provided for three months. Text Message: Text messages will be developed twice daily for three months None None 0 54 2 54 View
Standard Care + Text Message + ABT Participants in this arm will receive varenicline, plus twice daily adherence/motivational texts and seven phone developed Adherence Behavioral Therapy sessions Varenicline: Varenicline will be provided for three months. Text Message: Text messages will be developed twice daily for three months Adherence Behavioral Therapy: Seven Adherence Behavioral Therapy sessions will given over a three month period None None 0 51 7 51 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Changes in appetite SYSTEMATIC_ASSESSMENT General disorders None View
Vivd dreams or nightmares SYSTEMATIC_ASSESSMENT General disorders None View
Problem with sleeping SYSTEMATIC_ASSESSMENT General disorders None View
Skin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Peeling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Stomach Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Leg Pain SYSTEMATIC_ASSESSMENT General disorders None View