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 @ 2:03 AM
Ignite Modification Date: 2025-12-26 @ 12:27 AM
NCT ID: NCT03050060
Description: None
Frequency Threshold: 0
Time Frame: Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Study: NCT03050060
Study Brief: Image Guided Hypofractionated Radiation Therapy, Nelfinavir Mesylate, Pembrolizumab, Nivolumab and Atezolizumab in Treating Patients With Advanced Melanoma, Lung, or Kidney 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
Treatment (Nelfinavir, Immunotherapy, Radiation Therapy) Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution. Atezolizumab: Given IV Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Laboratory Biomarker Analysis: Correlative studies Nelfinavir Mesylate: Given PO Nivolumab: Given IV Pembrolizumab: Given IV 12 None 10 20 20 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
AST Increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
ALT increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Alk phos increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Glucose 149 SYSTEMATIC_ASSESSMENT Investigations None View
Increased Alkaline Phosphate SYSTEMATIC_ASSESSMENT Investigations None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cognitive Disturbance SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Congestion SYSTEMATIC_ASSESSMENT General disorders None View
Creatinine increase SYSTEMATIC_ASSESSMENT Investigations None View
Dermatitis Radiaiton SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Flashing Lights SYSTEMATIC_ASSESSMENT Eye disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gout SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Loss of appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lymphedema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Papulopustular rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lipase increase SYSTEMATIC_ASSESSMENT Investigations None View
Increased Serum Amylase SYSTEMATIC_ASSESSMENT Investigations None View
Skin Hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sleep apnea SYSTEMATIC_ASSESSMENT General disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Increased Serum Bilirubin SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hot Flashes SYSTEMATIC_ASSESSMENT General disorders None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Itchiness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Investigations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Increased AST SYSTEMATIC_ASSESSMENT Investigations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased ALT SYSTEMATIC_ASSESSMENT Investigations None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View