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 @ 4:26 PM
Ignite Modification Date: 2025-12-25 @ 2:19 PM
NCT ID: NCT02650466
Description: For each adverse event, the details of and circumstances will be recorded at the site and evaluated by the investigator in terms of relatedness, seriousness and the degree to which the event was anticipated.The adverse event will be reported to the sponsor and the Institutional Review Board; and will be followed by study personnel through to its resolution. All unanticipated adverse reactions, regardless of their severity, will be recorded as adverse events and reported to the sponsor.
Frequency Threshold: 0
Time Frame: Adverse Event data (including serious adverse event data) from 24 participants was collected on average for: 209 days (Range: 168-300 days) for the 17 participants who completed the study; and, 79 days (Range:0-217 days) from the 7 participants who did not complete the study.
Study: NCT02650466
Study Brief: Nanopulse Efficacy Study for the Treatment of Common Warts
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nanopulse Treatment None 0 None 0 24 1 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Local Sensory Abnormality SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View