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: 2025-12-25 @ 2:47 AM
Ignite Modification Date: 2025-12-26 @ 1:27 AM
NCT ID: NCT01836133
Description: All enrolled participants were included in the safety population.
Frequency Threshold: 5
Time Frame: Baseline up to 3 years
Study: NCT01836133
Study Brief: An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)
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 150 mg Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years. None None 19 70 21 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.19.1 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.19.1 View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v.19.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v.19.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v.19.1 View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v.19.1 View
Sudden death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v.19.1 View
Hyperbilirubinemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v.19.1 View
Hepatotoxicity NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v.19.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.19.1 View
Infectious pleural effusion NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.19.1 View
Conjuctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.19.1 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v.19.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v.19.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v.19.1 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v.19.1 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v.19.1 View
Azotaemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v.19.1 View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.19.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.19.1 View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.19.1 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.19.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v.19.1 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v.19.1 View
Superior vena cava syndrome NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v.19.1 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v.19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.19.1 View
Paronychia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v.19.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v.19.1 View