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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT00031460
Description: Twenty-two participants were enrolled into the placebo arm; however, only 21 received study drug.
Frequency Threshold: 5
Time Frame: Adverse events were followed throughout the 5 years of the study subject participation, or until subject terminated from the study. Subjects not completing 6 months of study drug were followed as intent to treat.
Study: NCT00031460
Study Brief: Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates
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 Oral suspension 300 mg/m\^2/dose TID for 6 months. None None 17 24 18 24 View
Placebo Identical volume as acyclovir. None None 15 21 13 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Decreased neutrophils SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Feeding dysfunction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastroesophageal reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Herpes simplex virus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rotavirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Strabismus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infantile spasms SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abscess SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Herpes simplex virus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View