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 @ 1:59 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT02935894
Description: None
Frequency Threshold: 0
Time Frame: Adverse events collected from November 2016 to June 2017 (6 months)
Study: NCT02935894
Study Brief: Investigating the Stability, Variability and Mechanism of Incorporation of Lipid Mediators Into Eccrine Sweat
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Group All subjects will participate in 4 study day visits in the same order. 1. compare sweat collected following pharmacological stimulation of sweating (using the drug pilocarpine) to sweat collected following physiological induction of sweating (exercise using a stationary bicycle). 2. compare sweat collected following stimulation of sweating by the drug pilocarpine from the inner part of the forearm (near the wrist) to upper surface of thigh (near the knee). 3. collect sweat following stimulation of sweating by the drug pilocarpine from the inner part of both forearms (near the wrist). 4. collect blood and sweat samples before and 30 minutes, 2 hours and 4 hours after consumption of 400 mg of ibuprofen. Ibuprofen: 400 mg ibuprofen given to inhibit COX metabolism Physiological induction of sweating: 15 minutes exercise at 60-80% oxygen consumption to induce sweating Pilocarpine: Iontophoresis with a 1.5 milliampere (mA) current using a gel disc containing a 5% pilocarpine 0 None 0 14 0 14 View
Serious Events(If Any):
Other Events(If Any):