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 @ 2:12 AM
Ignite Modification Date: 2025-12-26 @ 12:40 AM
NCT ID: NCT01217060
Description: Toxicity was documented according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.0 during the 10-week period beginning at the start of chemo-radiation and ending at the time of surgery, and post-surgery mortality (PostDeath), defined as death due to any cause during the 30-day period following surgery.
Frequency Threshold: 1
Time Frame: From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery
Study: NCT01217060
Study Brief: Trimodality Management of T1b Esophageal Cancers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Docetaxel + 5-FU + Radiation + Surgery Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation. 0 None 0 3 3 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diaphoresis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
Mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Radiation Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash (Hand-Foot skin reaction) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View