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 @ 10:49 PM
Ignite Modification Date: 2025-12-25 @ 8:19 PM
NCT ID: NCT02385669
Description: None
Frequency Threshold: 5
Time Frame: 3 months
Study: NCT02385669
Study Brief: A Phase I/II Trial to Evaluate a Peptide Vaccine Plus Ipilimumab in Patients With 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
6MHP and Ipilimumab The vaccine drug product, 6MHP, consists of 6 class II MHC-restricted peptides derived from melanoma proteins. Each vaccine consists of 200 mcg of each of the six peptides. An aqueous solution of vaccine is mixed 1/1 with Montanide ISA-51 to form water-in-oil emulsions. Vaccines are administered days 1, 8, 15, 43, 64, and 85. All peptide vaccines are administered intradermally and subcutaneously. Ipilimumab will be administered in accord with the official prescribing information: 3 mg/kg intravenously once every 3 weeks, for 4 doses. Ipilimumab will be administered on days 1, 22, 43, and 64. Ipilimumab: Checkpoint blockade inhibitor 6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides 0 None 1 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
uveitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (4.0) View
blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Other SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
skin induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View