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 @ 4:37 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT01108666
Description: Despite all possible efforts to contact the PI/study, data per dose-level are not available to be reported
Frequency Threshold: 0
Time Frame: 10 days
Study: NCT01108666
Study Brief: Proton Beam Radiation With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III Non Small Cell Lung Cancer (NSCLC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Proton RT and Nelfinavir Nelfinavir: Two dose levels of Nelfinavir will be evaluated in each concurrent chemotherapy group (carboplatin/paclitaxel and cisplatin/etoposide) at the RPTD does of proton beam radiotherapy: 625 and 1250 mg PO bid. 0 None 4 7 6 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemolytic uremic syndrome NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchial fistula NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alopecia NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Ear and labyrinth disorders NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophageal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroparesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral dysesthesia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Esophageal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucosal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dermatitis radiation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight gain NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Urinary tract pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hoarseness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleuritic pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View