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 @ 4:53 AM
Ignite Modification Date: 2025-12-26 @ 3:53 AM
NCT ID: NCT01579318
Description: None
Frequency Threshold: 5
Time Frame: From the start of study treatment up to 340 days.
Study: NCT01579318
Study Brief: Phase II Intratumoral IL12 Plasmid Electroporation in Cutaneous Lymphoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Participants received up to 4 cycles of treatment (3 daily treatments on Days 1, 5 and 8, in a 12-week cycle) of intratumoral injection(s) of tavo at a concentration of 1.0 mg/mL (maximum volume of 1 mL/day distributed over 2-4 lesions), followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid deoxyribonucleic acid (DNA) into tumor cells. None None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.1) View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.1) View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (19.1) View
Temperature intolerance SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.1) View
Actinic keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (19.1) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.1) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (19.1) View
Xerosis SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.1) View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (19.1) View