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 @ 11:07 PM
Ignite Modification Date: 2025-12-25 @ 8:39 PM
NCT ID: NCT03586869
Description: None
Frequency Threshold: 5
Time Frame: Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.
Study: NCT03586869
Study Brief: QUILT-3.080: NANT Pancreatic Cancer Vaccine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NANT Pancreatic Cancer Vaccine A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT). 3 None 2 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Mucosal dryness SYSTEMATIC_ASSESSMENT General disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nail injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Electrocardiogram T wave inversion SYSTEMATIC_ASSESSMENT Investigations None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Investigations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View