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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT04011033
Description: None
Frequency Threshold: 0
Time Frame: The occurrence of AEs was observed for an average of 24 weeks after the completion of treatment (between 0-11 weeks of treatment) for up to a 60 week period in total.
Study: NCT04011033
Study Brief: Study of Adoptive Transfer of iNKT Cells Combined With TAE/TACE to Treat Unresectable HCC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TAE/TACE+iNKT for Unresectable HCC TAE/TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TAE/TACE will be performed at 0th and 4th week. 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy. iNKT cells: 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 9th, 11th week after first TAE/TACE therapy. Human recombinated Interleukin-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion. TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week. 5 None 0 27 14 27 View
TAE/TACE for Unresectable HCC TAE/TACE will be conducted at 0th week and 4th week. TAE/TACE: TAE/TACE will be conducted to all patients at 0th week and 4th week. 4 None 0 27 15 27 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Callosity SYSTEMATIC_ASSESSMENT General disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Glutamyl transpeptidase increased SYSTEMATIC_ASSESSMENT Investigations None View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations None View