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 @ 2:33 AM
Ignite Modification Date: 2025-12-26 @ 1:09 AM
NCT ID: NCT01530334
Description: Adverse Events and Serious Adverse Events were collected from the time of screening informed consent throughout the treatment period, until 30 days after discontinuation of gefitinib treatment. Adverse events were based on sign and symptoms reported by the patients and on examinations and test
Frequency Threshold: 5
Time Frame: 24 months
Study: NCT01530334
Study Brief: Iressa Re-Challenge in Advanced NSCLC EGFR M+ Patients Who Responded to Gefitinib USed as 1st Line or Previous Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gefitinib 250 mg/die, oral None None 10 58 42 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 17 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 17 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 17 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 17 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 17 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 17 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA version 17 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 17 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 17 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 17 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 17 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 17 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrohea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 17 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 17 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 17 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 17 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 17 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 17 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 17 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 17 View
Skin toxicity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 17 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 17 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 17 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA version 17 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 17 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA version 17 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 17 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 17 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 17 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 17 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 17 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 17 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 17 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 17 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 17 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 17 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA version 17 View