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 @ 2:40 AM
Ignite Modification Date: 2025-12-26 @ 1:18 AM
NCT ID: NCT02312934
Description: Adverse events were recorded and categorized by body system, event type, attribution, frequency, severity, and course. AEs were assessed across all double-blind study visits and categorized according to body system for all participants who received at least one dose of patches (nicotine n = 12, placebo n = 13).
Frequency Threshold: 0
Time Frame: 8-Weeks
Study: NCT02312934
Study Brief: Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm. Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal Placebo Transdermal Patch 0 None 0 11 8 11 View
Transdermal Nicotine Nicotine will be delivered by a transdermal patch delivery system for topical application. Each patch will contain approximately 1.75mg nicotine/cm2, and releases 7, and 14mg of nicotine, respectively, over 24 hours. Patches will be applied for 16 hours per day. Participants will be titrated over the course of the 6-week treatment period in order to avoid initial side effects as follows: Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal Transdermal nicotine: Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence. 0 None 0 11 7 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin Irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neurologic SYSTEMATIC_ASSESSMENT General disorders None View
Mood SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View