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: 2025-12-26 @ 10:58 AM
Ignite Modification Date: 2025-12-26 @ 10:58 AM
NCT ID: NCT00815308
Description: None
Frequency Threshold: 1.81
Time Frame: None
Study: NCT00815308
Study Brief: Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cetuximab, Concurrent Chemo-radiotherapy Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8 None None 2 55 38 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
esophago-tracheal fistula SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hepatic Functional Lesion SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Granulocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Skin Eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
granlopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
radiodematitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
mucositis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
radioacitvity esophagitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View