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 @ 4:08 PM
Ignite Modification Date: 2025-12-25 @ 2:08 PM
NCT ID: NCT00371566
Description: Safety population used in this analysis consisting of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.
Frequency Threshold: 5
Time Frame: Started prior to and during Lapatanib/Placebo phase, during or after chemoradiotherapy phase.
Study: NCT00371566
Study Brief: A Study Of Lapatinib Versus Placebo Followed By Chemoradiation In Patients With Locally Advanced 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
Placebo Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care) None None 14 36 36 36 View
Lapatinib Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of mor than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care). None None 14 69 69 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Abdominal strangulated hernia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
General Physical Health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sudden Death SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bipolar Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Peripheral Embolism SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Lobar Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Septic Shock SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Diabetic Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Electrolyte Imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Ventricular Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Renal Impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pneumonia Aspirations SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Post Procedural Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Weight Decrease SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Ventricular fibrillation None Cardiac disorders None View
Pneumonia aspiration None Respiratory, thoracic and mediastinal disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Post procedural hemorrhage None Injury, poisoning and procedural complications None View
Ketoacidosis None Metabolism and nutrition disorders None View
Renal impairment None Renal and urinary disorders None View
Weight decreased None Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mucosal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Radiation Skin Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pain None General disorders None View
Pyrexia None General disorders None View
Soft tissue inflammation None General disorders None View
Oedema None General disorders None View
Face oedema None General disorders None View
Oral pain None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Aphthous stomatitis None Gastrointestinal disorders None View
Aptyalism None Gastrointestinal disorders None View
Toothache None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Mouth hemorrhage None Gastrointestinal disorders None View
Oesophagitis None Gastrointestinal disorders None View
Skin reaction None Skin and subcutaneous tissue disorders None View
Dehydration None Metabolism and nutrition disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Candidiasis None Infections and infestations None View
Oral candidiasis None Infections and infestations None View
Respiratory tract infection None Infections and infestations None View
Oropharyngeal candidiasis None Infections and infestations None View
Dermatitis None Skin and subcutaneous tissue disorders None View
Erythema None Skin and subcutaneous tissue disorders None View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Anemia None Blood and lymphatic system disorders None View
Leukopenia None Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia None Blood and lymphatic system disorders None View
Weight decreased None Blood and lymphatic system disorders None View
Blood creatinine increased None Blood and lymphatic system disorders None View
Dysgeusia None Nervous system disorders None View
Headache None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View
Radiation mucositis None Injury, poisoning and procedural complications None View
Neck pain None Musculoskeletal and connective tissue disorders None View
Trismus None Musculoskeletal and connective tissue disorders None View
Hypoacusis None Ear and labyrinth disorders None View
Ear pain None Ear and labyrinth disorders None View
Tinnitus None Ear and labyrinth disorders None View
Pallor None Vascular disorders None View
Hypertension None Vascular disorders None View