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 @ 12:39 PM
Ignite Modification Date: 2025-12-25 @ 12:12 PM
NCT ID: NCT01990261
Description: None
Frequency Threshold: 5
Time Frame: Up to 12 months
Study: NCT01990261
Study Brief: A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy 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
Erlotinib Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. None None 7 33 3 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ischaemic limb pain SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Anaemia of malignant disease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Pleural neoplasms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View