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 @ 5:40 PM
Ignite Modification Date: 2025-12-25 @ 3:10 PM
NCT ID: NCT04553068
Description: None
Frequency Threshold: 4
Time Frame: 16 weeks
Study: NCT04553068
Study Brief: Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Gel Placebo vaginal gel, 5 g Placebo: Placebo vaginal gel 0 None 9 937 28 937 View
EVO100 Gel EVO100 vaginal gel, 5 g EVO100: EVO100 vaginal gel 0 None 4 926 39 926 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pancreatic contusion NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
blood loss anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
alcohol poisoning NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
craniocerebral injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
adenomyosis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
COVID-19 pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
fallopian tube abscess NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
tubo-ovarian abscess NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
abortion missed NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
abortion spontaneous NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
vaginal discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View