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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:46 PM
NCT ID: NCT03898167
Description: Study participants were asked to report any adverse events during the use of the HPV self-collection kit. Reported AEs were assessed within 6 months of randomization.\*\* \*\*AEs are for when participants are "on treatment" so would have been within 6 months post randomization.
Frequency Threshold: 0
Time Frame: Within 6 months post randomization
Study: NCT03898167
Study Brief: Prospective Evaluation of Self-Testing to Increase Screening
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Telephone Recall Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System. Telephone Recall: Participants receive a scripted telephone recall from a trained patient navigator. 0 None 0 828 0 828 View
Mailed HPV Self-Sampling Kit + Patient Navigation Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education. Telephone Recall: Participants receive a scripted telephone recall from a trained patient navigator. Mailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing. Patient Navigation: Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample. 0 None 0 818 1 818 View
Mailed HPV Self-Sampling Kit Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a pre-paid return envelope. Telephone Recall: Participants receive a scripted telephone recall from a trained patient navigator. Mailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing. 0 None 0 828 0 828 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View