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: 2025-12-25 @ 5:09 AM
Ignite Modification Date: 2025-12-26 @ 4:13 AM
NCT ID: NCT00387127
Description: Data are presented for the Safety Population (SP)=participants (par.) who were randomized and took \>=1 dose of study medication (SM). One par. randomized to placebo received lapatinib in error and was assigned to the lapatinib arm in the SP. One par. randomized to placebo withdrew from the study prior to receiving SM and was not included in the SP.
Frequency Threshold: 5
Time Frame: Data are presented as of the cut-off date of 1-August-2014.
Study: NCT00387127
Study Brief: Lapatinib Versus Placebo Given Concurrently With Cisplatin And Radiotherapy In Patients With Unresected Head And Neck 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
Chemoradiotherapy + Placebo, Followed by Placebo Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal. None None 18 31 31 31 View
Chemoradiotherapy + Lapatinib, Followed by Lapatinib Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m\^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal. None None 22 35 34 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pharyngeal Ulceration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Quadriparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal Failure Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Soft Tissue Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Staphylococcal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Squamous cell carcinoma of the tongue SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Renal Tubular Disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Tumor Hemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Arterial Occlusive Disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Creatinine Renal Clearance Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Ejection Fraction Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gastrointestinal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastrostomy Failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Left Ventricular Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Localised Edema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Lung Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Metastatic Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Mouth Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Obstructive Airways Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Parotid Gland Inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oral Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Radiation Skin Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin Reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Localized Edema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Creatinine Renal Clearance Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Radiation Mucositis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oral Fungal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Gastroesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Laryngeal Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Edema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Aptyalism SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Epiglottic Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Increased Upper Airway Secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Increased Viscosity of Bronchial Secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Mouth Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Salivary Gland Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Aphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Blood Sodium Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood Urea Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Depressed Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Face Edema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Neutrophil Count Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Tongue Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Aphonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Aplasia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Catheter Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Ejection Fraction Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Fibrosis SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gamma Glutamyltransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Glossitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Nail Disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dental caries SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral mucosal erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Trismus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View