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 @ 4:43 PM
Ignite Modification Date: 2025-12-25 @ 2:31 PM
NCT ID: NCT01042366
Description: Adverse events were not collected/monitored per Arm/Group
Frequency Threshold: 0
Time Frame: None
Study: NCT01042366
Study Brief: Dendritic Cells (DC) Vaccine for Metastatic Melanoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants (Overall Study) For all arms: DC vaccine Co-cultured With Melanoma Cells; DC Vaccine Pulsed With Tumor Cell Lysates; DC Vaccines Fused With Tumor Cells None None 1 15 11 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatic-Other SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue (lethargy, malaise, asthenia) SYSTEMATIC_ASSESSMENT General disorders None View
Constitutional Symptoms-Other SYSTEMATIC_ASSESSMENT General disorders None View
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) SYSTEMATIC_ASSESSMENT General disorders None View
Dermatology/Skin-Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea patients without colostomy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Taste disturbance (dysgeusia) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal-Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia, esophagitis, odynophagia (painful swallowing) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
SGPT (ALT) (serum glutamic pyruvic transaminase) SYSTEMATIC_ASSESSMENT Investigations None View
Hepatic-Other SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations None View
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Musculoskeletal-Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurology-Other SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness/lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mood alteration-anxiety, agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mood alteration-depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Tumor pain (onset or exacerbation of tumor pain due to treatment) SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dyspnea (shortness of breath) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Platelets SYSTEMATIC_ASSESSMENT Investigations None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspepsia/heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lymphatics-Other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathic pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy-sensory SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain-Other SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View