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 @ 7:37 PM
Ignite Modification Date: 2025-12-25 @ 5:17 PM
NCT ID: NCT03433703
Description: None
Frequency Threshold: 0
Time Frame: From the first dose of study drug up to 28 days after the last dose of study drug (approximately 3 months)
Study: NCT03433703
Study Brief: Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lenvatinib Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW \>=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW \<60 kg - lenvatinib 8 mg (taken as two 4 mg capsules). 0 None 1 2 1 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View