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 @ 3:05 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT04072159
Description: We asked clinic staff to report any adverse events related to the study to our study staff. Additionally, in our study informed consent document, we asked participants to notify us (by calling the study principal investigator) of any adverse events.
Frequency Threshold: 0
Time Frame: We monitored adverse events monthly with our study staff when they worked in the clinic from April 2019 - February 2020 (10 months).
Study: NCT04072159
Study Brief: Community Pharmacists Vaccinate Against Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pharmacist-Administered HPV Vaccine Series Completion Group For the Pharmacist-Administered HPV Vaccine Series Completion group, primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacy. Community Pharmacists Vaccinating Against Cancer: Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant. 0 None 0 16 0 16 View
Primary Care Provider HPV Vaccine Series Completion Primary Care Provider HPV Vaccine Series Completion group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care). 0 None 0 17 0 17 View
Serious Events(If Any):
Other Events(If Any):