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 @ 12:38 AM
Ignite Modification Date: 2025-12-25 @ 10:48 PM
NCT ID: NCT02265367
Description: Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
Frequency Threshold: 5
Time Frame: Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Study: NCT02265367
Study Brief: Novel Medication as a Potential Smoking Cessation Aid
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 In this three week period, baseline measures are obtained during the first week, placebo will be started during the second week and effects on smoking behavior will be assessed during the third week Placebo 0 None 0 51 26 51 View
Levomilnacipran In this three week period, baseline measures are obtained during the first week, levomilnacipran will be started during the second week and effects on smoking behavior will be assessed during the third week Levomilnacipran 0 None 0 52 37 52 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sleep / Energy Changes NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal Symptoms NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Changes in Mood, Anxiety or Irritability Level NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Excessive Sweating NON_SYSTEMATIC_ASSESSMENT General disorders None View
Body aches / pains NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Change in Appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cold / Seasonal Allergy Symptoms NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View