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 @ 4:58 PM
Ignite Modification Date: 2025-12-25 @ 2:39 PM
NCT ID: NCT00633750
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00633750
Study Brief: Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tarceva Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva. None None 1 47 44 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary ebmolisim None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain None Gastrointestinal disorders None View
Alkaline phosphatase None Investigations None View
Fatigue None General disorders None View
SGPT (ALT) None Investigations None View
Allergic rhinitis None Respiratory, thoracic and mediastinal disorders None View
Anorexia None Metabolism and nutrition disorders None View
Arrhythmia None Cardiac disorders None View
Arthiritis None Musculoskeletal and connective tissue disorders None View
Blurred vision None Eye disorders None View
Constipation None Gastrointestinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Headache None Nervous system disorders None View
Hemoglobin None Investigations None View
Hypercalcemia None Metabolism and nutrition disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypertension None Vascular disorders None View
Hypothyroidism None Endocrine disorders None View
Infection (without neutropenia) None Infections and infestations None View
Insomnia None Psychiatric disorders None View
Joint, muscle or bone pain None Musculoskeletal and connective tissue disorders None View
Mood Changes - depression None Psychiatric disorders None View
Mood Changes-anxiety/agitation None Psychiatric disorders None View
Mucositis None Gastrointestinal disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Nausea None Gastrointestinal disorders None View
Pain None General disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Hot flashes/flushes None Vascular disorders None View
High cholesterol None Investigations None View
Sinus infection None Respiratory, thoracic and mediastinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View