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 @ 3:09 AM
Ignite Modification Date: 2025-12-26 @ 1:48 AM
NCT ID: NCT03725605
Description: None
Frequency Threshold: 5
Time Frame: AEs were collected from the day the subject signed the informed consent and for up to 15 months.
Study: NCT03725605
Study Brief: LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LTX-315 plus TIL infusion LTX-315 intratumoural injection, TILs expansion and infusion. LTX-315 and TILs: Intratumoural injection of LTX-315 and infusion of TILs 0 None 3 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Fascial rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gastric disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Oral fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood alkaline phosphatase decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Transaminases decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Facial paresis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View