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 @ 4:31 PM
Ignite Modification Date: 2025-12-25 @ 2:23 PM
NCT ID: NCT00101166
Description: As in our Phase I study, there were no recorded systemic toxicities associated with the vaccine.
Frequency Threshold: 0
Time Frame: Average of 14 months. Every 4 weeks throughout the 4 month treatment phase and every 3 months thereafter.
Study: NCT00101166
Study Brief: Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vaccine Therapy Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57. Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm. None None 0 28 10 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain - Cardiac - Unrelated SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE-3 View
Transient localized erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE-3 View
mild pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE-3 View
Localized depigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE-3 View
Induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE-3 View