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 @ 2:52 AM
Ignite Modification Date: 2025-12-26 @ 1:33 AM
NCT ID: NCT00996333
Description: AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Frequency Threshold: 0
Time Frame: None
Study: NCT00996333
Study Brief: Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gemzar, Taxotere, Xeloda Gemcitabine, Docetaxel, Capecitabine: Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11 This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles. None None 16 45 3 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Alveolitis leading to death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Leg edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever and chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever and infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Temporary loss of vision in the right eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Small bowel NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancytopenia and diarrhea NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lower abdominal and back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leukopenia and hypotension NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sepsis and neutropenia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Port-a-cath NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Shortness of breath NON_SYSTEMATIC_ASSESSMENT General disorders None View
Blood clot NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation, nausea and vomiting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyponatremia and elevated liver enzymes NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Death due to unknown reason NON_SYSTEMATIC_ASSESSMENT General disorders None View
Heart attack leading to death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View