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 @ 4:59 AM
Ignite Modification Date: 2025-12-26 @ 3:59 AM
NCT ID: NCT01065818
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01065818
Study Brief: Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluoro-L-Thymidine Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery. Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery. Only 5 subjects were followed for AEs/SAEs since one subject withdrew consent prior to any participation in the study. 0 None 3 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Liver Function NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Allergic Reaction to Chemotherapy NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abnormal Complete Blood Count (CBC) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood Glucose Level Increased NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
ALT Increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Odynophagia NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
White Blood Cell (WBC) Count Increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View