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 @ 2:54 PM
Ignite Modification Date: 2025-12-25 @ 1:19 PM
NCT ID: NCT00833859
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT00833859
Study Brief: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chemotherapy Followed by Radiation Treatment Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25. None None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Intermittent hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTC V3 View
Pale skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Itchy rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Hand foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC V3 View
Dizziness/lightheadedness SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Presyncope SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Chest tightness SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC V3 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Increased fatigue SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Insomia SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Cracks on lips SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Cracks on feet SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Red peeling spots on arms SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Yellow stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Hemorrhoid SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Malabsorption SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Mouth sores SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Intermittent nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Taste alteration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Calf tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC V3 View
Sort throat/redness SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Voice changes (raspy) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC V3 View