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: 2025-12-24 @ 7:17 PM
Ignite Modification Date: 2025-12-25 @ 4:55 PM
NCT ID: NCT02047903
Description: None
Frequency Threshold: 5
Time Frame: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
Study: NCT02047903
Study Brief: GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Afatinib Participants with locally advanced and /or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations received orally 40 milligram (mg) or less than 40 mg Afatinib starting dose once daily as first-line therapy. With dose escalation to maximum of 50 mg/day and reduction to 30 mg/day or 20 mg/day according to the summary of product characteristics (SmPC) under routine clinical conditions. The dose should not be escalated in any participant with a prior dose reduction. 73 None 65 152 144 152 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Pneumobilia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.1 View
Arthritis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Dermatitis exfoliative generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Thrombotic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Mitral valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Anal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Enteritis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Intervertebral discitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Oesophageal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Bronchial obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Stevens-Johnson syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Spinal operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21.1 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Dermatitis exfoliative generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View