Adverse Events Module

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 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:03 AM
NCT ID: NCT00531934
Description: None
Frequency Threshold: 0
Time Frame: Adverse events (AEs) were recorded continuously until 30 days after the last treatment administration.
Study: NCT00531934
Study Brief: A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung 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
Erlotinib Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity. None None 24 74 69 74 View
Erlotinib + Doxycycline Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline. None None 18 73 71 73 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Colonic obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Staphylococcal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Intracranial pressure increased NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Death NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Lung disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Bronchitis chronic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Xerosis NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Phlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Rhabdomyolysis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Oesophageal achalasia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Aphthous stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Gastrointestinal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Abdominal rigidity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Aerophagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Faecaloma NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Gingival bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Gingival hypertrophy NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Gingivitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hiatus hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Salivary hypersecretion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Subileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Xerosis NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Pertussis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Vaginal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Eye pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Growth of eyelashes NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Ocular hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Visual distrubance NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Groin pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Laryngeal disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Diabetes mellitus inadequate control NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Aphonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dementia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dysarthria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Epiduritis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Facial neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Parosmia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Vocal cord paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Liver function test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
White blood cell count increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Phlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Periphlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Venous thrombosis limb NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Cardiac tamponade NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Cytolytic hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Cholestasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Eschar NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Traumatic haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (3.0) View
Cerumen impaction NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (3.0) View
Ear haemorrhage NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (3.0) View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Adrenal insufficiency NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (3.0) View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (3.0) View
Vulvovaginal dryness NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Paronychia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hypertrichosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Nail disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Intertrigo NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hyperkeratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Ingrowing nail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Skin discolouration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Catheter site inflammation NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hyperthermia NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Fungal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Oral fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Staphylococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Bronchitis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Bronchopulmonary aspergillosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Central line infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Conjunctivitis infective NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Gingival pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Glossitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View