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 @ 1:30 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT00003895
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00003895
Study Brief: Vaccine Therapy in Treating HLA-A2 Positive 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
Arm A (Every 2 Weeks) Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity. HPV 16 E7:12-20 peptide vaccine: Given SC gp100:209-217(210M) peptide vaccine: Given SC laboratory biomarker analysis: Correlative studies None None 1 18 18 18 View
Arm B (Every 3 Weeks) Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity. HPV 16 E7:12-20 peptide vaccine: Given SC gp100:209-217(210M) peptide vaccine: Given SC laboratory biomarker analysis: Correlative studies None None 0 18 17 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CVA None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain None Musculoskeletal and connective tissue disorders None View
Fatigue None General disorders None View
Neuropathy None Nervous system disorders None View
Depression None Nervous system disorders None View
Endocrine-Other None Endocrine disorders None View
Nausea None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Chills None General disorders None View
Edema None Vascular disorders None View
Anorexia None Gastrointestinal disorders None View
Dysguesia None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Vomiting None Gastrointestinal disorders None View
Stomatitis None General disorders None View
Dizziness None Nervous system disorders None View
Insomnia None Nervous system disorders None View
Fever None General disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Dry Mouth None Gastrointestinal disorders None View
Injection Site Reaction None Skin and subcutaneous tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Anxiety None Nervous system disorders None View