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 @ 3:45 PM
Ignite Modification Date: 2025-12-25 @ 1:53 PM
NCT ID: NCT01290692
Description: Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.
Frequency Threshold: 0
Time Frame: 32 months
Study: NCT01290692
Study Brief: Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TVI-Brain-1 All patients will receive the full TVI-Brain-1 treatment. TVI-Brain-1: Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood. 14 None 9 14 5 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fever and Chills SYSTEMATIC_ASSESSMENT Immune system disorders None View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders None View
disorientation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hemiparesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hemisensory Neglect SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypomagnesae SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Redness at injection sites SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Generalized Aching SYSTEMATIC_ASSESSMENT General disorders None View
Infusion Site irritation/pain SYSTEMATIC_ASSESSMENT General disorders None View
Rigors SYSTEMATIC_ASSESSMENT General disorders None View
Calcium Low SYSTEMATIC_ASSESSMENT Investigations None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View