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 @ 3:38 PM
Ignite Modification Date: 2025-12-25 @ 1:49 PM
NCT ID: NCT03689192
Description: None
Frequency Threshold: 1
Time Frame: Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
Study: NCT03689192
Study Brief: Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ARG1-18,19,20 Peptide Vaccine One ARG1-vaccine every third week for 45 weeks. ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide 9 None 3 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Facial paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatique SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Xerostomia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Granuloma at injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypothyroidsm SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Transaminase elevation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Alkaline phosphate increased SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View