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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:47 PM
NCT ID: NCT03557294
Description: No different
Frequency Threshold: 5
Time Frame: Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
Study: NCT03557294
Study Brief: Varenicline OTC Trial on Efficacy and Safety
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.0mg Placebo Varenicline b.i.d. Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily. 0.0mg placebo Varenicline b.i.d.: Product that looks like active varenicline, but contains no active ingredient 0 None 2 105 35 105 View
1.0mg Varenicline b.i.d. Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily. 1.0mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype. 0 None 0 104 49 104 View
0.5mg Varenicline b.i.d. Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study 0.5mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype. 0 None 0 104 43 104 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stab Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Asthma Attack SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Vivid Dreams SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View