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: 2025-12-25 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:32 PM
NCT ID: NCT03021993
Description: None
Frequency Threshold: 5
Time Frame: 12 months post surgery
Study: NCT03021993
Study Brief: Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nivolumab Nivolumab (OPDIVO) will be administered every two weeks for up to four doses prior to surgery at 3mg/kg Nivolumab: Nivolumab will be administered on days 1, 15 and 29. If disease has progressed at day 29, the subject will proceed to surgery. If a response or stable disease is present after the third dose, a fourth dose will be given on day 43, then the subject will proceed to surgery. 3 None 1 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypercalcemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Painful Swelling In R Submandibular Node SYSTEMATIC_ASSESSMENT General disorders None View
Papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hearing Impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral Pain SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
muscositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thrush SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsened Tongue Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Xerostomia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Numbness Of Tongue SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Opiod Induced Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tongue Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Edema Face SYSTEMATIC_ASSESSMENT General disorders None View
Worsened Appetite SYSTEMATIC_ASSESSMENT General disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Leg Wound Infection At Site Of Graft SYSTEMATIC_ASSESSMENT Infections and infestations None View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right Hand Swollen SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stiffness in Arms/Legs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
T8 Compression Deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthritis Feeling In Thighs And Arms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stiff Neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin None View
Pruritic Rash Shoulder SYSTEMATIC_ASSESSMENT Skin None View
Psoriasis SYSTEMATIC_ASSESSMENT Skin None View
Actinic Keratosis SYSTEMATIC_ASSESSMENT Skin None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View