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 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:32 PM
NCT ID: NCT00710593
Description: Participants were considered to have a vaccine-associated sign and/or symptom if they had at least one sign/symptom during the study after each vaccination, and the sign/symptom is possibly, probably, or definitely related to vaccine.
Frequency Threshold: 5
Time Frame: 24 Weeks
Study: NCT00710593
Study Brief: Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A: HAART naïve or, if HAART Exposed, Has Not Received HA Participants who are ART naïve or, if ART-exposed, have not received HAART for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24). None None 0 69 34 69 View
Group B: Has Been Receiving HAART for > 6 Months, With Two HIV Participants who have been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads \< 400 copies/ml on two previous clinical visits within the 6 months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24). None None 0 30 14 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Local reactions SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Systemic Reactions SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Other Reactions SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View