Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 7:23 PM
Ignite Modification Date: 2025-12-25 @ 5:02 PM
NCT ID: NCT00153803
Description: Common Toxicities are reported. Adverse events (Serious, Other Adverse Events) are reporting for only those participants who are included in the intent-to-treat population .This study used the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0 for grading and reporting of toxicities and adverse events.
Frequency Threshold: 0
Time Frame: The intent-to-treat population included 235 eligible randomized patients to the erlotinib arm (n = 118) or placebo arm (n = 117); 245 randomized, 10 became ineligible prior to any treatment. Patients were evaluated with a medical history, physical exam, laboratory studies, and toxicity assessment starting at 1st dose, every 4 weeks for 2 months, then every 8-12 weeks until treatment discontinuation. Participants were evaluated, on average, for 6 months, and through study completion up to 3 years
Study: NCT00153803
Study Brief: Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in 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
Chemoradiation Before Tarceva None 26 None 36 118 12 118 View
Chemoradiation Before Placebo None 27 None 38 117 8 117 View
Tarceva Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy. 43 None 39 77 8 77 View
Placebo Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy. 40 None 23 75 0 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemorrhage - Respiratory tract NOS SYSTEMATIC_ASSESSMENT General disorders None View
Infection - Wound SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac General SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac ischemia/infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Paroxysmal Atrial Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia (difficulty swallowing) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fistula, Esophagus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal - Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis/stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Perforation, GIColon SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constitutional Symptoms - Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Constitutional Symptoms - Fever SYSTEMATIC_ASSESSMENT General disorders None View
Constitutional Symptoms- Other SYSTEMATIC_ASSESSMENT General disorders None View
Hemorrhage, GI Lower SYSTEMATIC_ASSESSMENT General disorders None View
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary SYSTEMATIC_ASSESSMENT General disorders None View
Hemorrhage, pulmonary/upper respiratory- Lung SYSTEMATIC_ASSESSMENT General disorders None View
Hemorrhage/Bleeding - Other SYSTEMATIC_ASSESSMENT General disorders None View
Pain - Abdomen NOS SYSTEMATIC_ASSESSMENT General disorders None View
Pain - Bone SYSTEMATIC_ASSESSMENT General disorders None View
Pain - Joint SYSTEMATIC_ASSESSMENT General disorders None View
Pain - Other SYSTEMATIC_ASSESSMENT General disorders None View
Pain- Chest/thorax SYSTEMATIC_ASSESSMENT General disorders None View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Colitis, Infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection - Blood SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection - Foreign body SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection - Lung SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection - Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal / Soft Tissue - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cerebrovascular Ischemia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurology - Other SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence/depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Obstruction - Ureter SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspnea (shortness of breath) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion (non-malignant) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis/pulmonary infiltrates SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper Respiratory - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin - Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Wound complication, non-infectious SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Intra-operative Injury - Other SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Thrombosis/embolism (vascular access-related) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombosis/thrombus/embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vascular - Other SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac General - Other SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constitutional symptoms - Fever SYSTEMATIC_ASSESSMENT General disorders None View
Skin - Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal - Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain - Chest/Thorax SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonitis/pulmonary infiltrates SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain - Abdomen NOS SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory - other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection - Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Extrapyramidal/involuntary movement/restlessness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain - Other SYSTEMATIC_ASSESSMENT General disorders None View
Desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View