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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:46 PM
NCT ID: NCT03631667
Description: The definitions of adverse event and serious adverse event used to determine incidence are consistent with clinicaltrials.gov definitions. Each participant was verbally asked about the occurrence of adverse events at each clinical visit by the research nurse.
Frequency Threshold: 0
Time Frame: 48.5 hours for each of 2 dosing cycles with a 3-week washout period between the dosing cycles. Participants were assessed for adverse events 15 minutes prior to the [14c]-BaP dose administration (time= 0 hour) until 15 minutes after the final blood sample collection time point (time = 48 hour) and removal of the peripheral IV catheter.
Study: NCT03631667
Study Brief: Ultralow Dose PAH Binary Mixture 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
50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP). Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP) and 1250 phenanthrene. At least 3 weeks must pass between each capsule dose administration. \[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi) \[14C\]-benzo\[a\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene plus 1250 ng phenanthrene 0 None 0 5 0 5 View
Serious Events(If Any):
Other Events(If Any):