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 @ 4:52 AM
Ignite Modification Date: 2025-12-26 @ 3:53 AM
NCT ID: NCT00527618
Description: Assessment of any adverse events was performed at each weekly clinic visit during the trial by a study investigator, including 12 weeks during acyclovir administration, 12 weeks during valacyclovir administration and 2 weeks during the washout period.
Frequency Threshold: 5
Time Frame: 26 weeks
Study: NCT00527618
Study Brief: Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and 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
Acyclovir Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods) None None 1 32 4 32 View
Valacyclovir Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods) None None 0 30 3 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Resipiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Yeast vaginitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View