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 @ 6:44 PM
Ignite Modification Date: 2025-12-25 @ 4:15 PM
NCT ID: NCT01550757
Description: We submitted an amendment about adverse events. It outlined "expected AEs" commonly seen in the homeless population. As this study is considered "low risk" and unrelated to specific disease management, we defined the medical management issues/expected hospitalizations we anticipated among our homeless cohort. In accordance with all VA policies, we report all unexpected events occurring during study participation, events impacting research staff, and any events involving research privacy.
Frequency Threshold: 0
Time Frame: Adverse event data were collected during active enrollment in the randomized controlled trial, May 2012 - March 2014 (22 months).
Study: NCT01550757
Study Brief: Aligning Resources to Care for Homeless Veterans
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1: Normal PACT Clinical Care Normal Patient Aligned Care Team Clinical Care 1 None 0 56 0 56 View
Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor Normal PACT Clinical Care + Embedded Peer Mentor Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research. 0 None 0 52 0 52 View
Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research. 1 None 0 144 0 144 View
Arm 3: Normal Homeless Oriented PACT Clinical Care Normal Homeless Oriented Patient Aligned Care Team Clinical Care 1 None 0 130 0 130 View
Serious Events(If Any):
Other Events(If Any):