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 @ 5:12 AM
Ignite Modification Date: 2025-12-26 @ 4:17 AM
NCT ID: NCT05965427
Description: Adverse events were not assessed for this study, only deaths and hospitalisations were collected.
Frequency Threshold: 0
Time Frame: From date of disease onset/first symptom, D0, until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) D90
Study: NCT05965427
Study Brief: Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PLWHIV and Mpox Coinfection People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023. 0 None 57 946 0 0 View
HIV Negative PrEP Users With Mpox Infection PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023. 0 None 38 1054 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalisation SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):