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 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:10 PM
NCT ID: NCT02426658
Description: None
Frequency Threshold: 5
Time Frame: 30 days after the last study is administered
Study: NCT02426658
Study Brief: Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3
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 (Pemetrexed Disodium) Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment and Laboratory Biomarker Analysis. Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV Quality-of-Life Assessment: QOL studies 4 None 12 13 12 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.0 View
Death, NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE version 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE version 4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Cardiac disorders, other SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.0 View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE version 4.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE version 4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
General disorders and administration site disorders, other SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE version 4.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE version 4.0 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.0 View
Investigations, other SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.0 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Metabolism and nutrition disorders, other SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Mucositis, oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.0 View
Rash pustular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.0 View
Skin and subcutaneous tissue disorders, other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 4.0 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders CTCAE version 4.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View