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 @ 3:38 AM
Ignite Modification Date: 2025-12-26 @ 2:23 AM
NCT ID: NCT03887702
Description: No participants received experimental treatment on this study. No participants were registered in the Chronic HBV cohort \[Cohort 1\]. In the Past HBV cohort \[Cohort 2\]: * no participants assigned to Arm 3 experienced HBV reactivation, which would have prompted treatment with the study-assigned anti-HBV therapy according to protocol * one participant in Arm 4 (standard of care) began anti-HBV therapy at physician discretion.
Frequency Threshold: 0
Time Frame: Adverse event data were collected over 2 years, but, with the exception of study endpoints, adverse events were only collected after participants began treatment with anti-HBV therapy.
Study: NCT03887702
Study Brief: Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1 (TAF, TDF, Entecavir: Prophylactic) \[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity. Entecavir: Given PO Tenofovir Alafenamide: Given PO Tenofovir Disoproxil Fumarate: Given PO 0 None 0 0 0 0 View
Arm 2 (TAF, TDF, Entecavir: Upon Indication) \[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity. Entecavir: Given PO Tenofovir Alafenamide: Given PO Tenofovir Disoproxil Fumarate: Given PO 0 None 0 0 0 0 View
Arm 3 (TAF, TDF, Entecavir: Upon Indication) \[Cohort 2\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity. Entecavir: Given PO Tenofovir Alafenamide: Given PO Tenofovir Disoproxil Fumarate: Given PO 0 None 0 2 0 2 View
Arm 4 (Anti-Viral Therapy: Usual Care) \[Cohort 2\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for HBV may be used. 0 None 0 2 0 2 View
Serious Events(If Any):
Other Events(If Any):