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 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:02 AM
NCT ID: NCT00000134
Description: None
Frequency Threshold: 1
Time Frame: 1 year, 4 months
Study: NCT00000134
Study Brief: Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intravenous Ganciclovir intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day None None 41 93 7 93 View
Combination Therapy combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day. Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day None None 51 93 10 93 View
Intravenous Foscarnet intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day None None 32 88 7 88 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders serious View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders other View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hospitalizations SYSTEMATIC_ASSESSMENT Infections and infestations other View