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 @ 2:59 AM
Ignite Modification Date: 2025-12-26 @ 1:40 AM
NCT ID: NCT02417233
Description: "0 participants at risk" included because: Serious and Other Adverse Events were not monitored/assessed in this study because it was not a clinical trial of a new drug or device, but rather, a behavioral intervention. Study staff were not clinicians - only data monitoring assistants and peer health navigators. The study was based in a public clinic system, but the only clinical data abstracted for the study was for the study outcomes described. Other medical data was not recorded.
Frequency Threshold: 0
Time Frame: "0 participants at risk" included because: Serious and Other Adverse Events were not monitored/assessed in this study because it was not a clinical trial of a new drug or device, but rather, a behavioral intervention. Study staff were not clinicians - only data monitoring assistants and peer health navigators. The study was based in a public clinic system, but the only clinical data abstracted for the study was for the study outcomes described. Other medical data was not recorded.
Study: NCT02417233
Study Brief: Engagement to Care South Africa
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SMS Text Message Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also automated bi-weekly "check-in" text messages that will trigger a phone call from clinic staff if the participant reports not being well. SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages 10 None 0 0 0 0 View
SMS Text Message + Peer Navigation Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also bi-weekly contact from an HIV-positive peer who provides personalized support and with health or other service systems navigation assistance. SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation 14 None 0 0 0 0 View
Standard of Care Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime) only. This group will not receive any additional engagement to care intervention. 4 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):