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 @ 10:18 PM
Ignite Modification Date: 2025-12-25 @ 7:51 PM
NCT ID: NCT00503035
Description: Adverse events accessed for the participants who received celecoxib for any duration on the study.
Frequency Threshold: 1
Time Frame: Study subjects were contacted by phone 72 hr. after the first celecoxib doses and every 2 weeks thereafter for the rest of the celecoxib treatment duration for toxicity assessment. In addition, subjects had evaluation for toxicity as part of history and physical during a clinical visit at the end of the treatment, at 6 months
Study: NCT00503035
Study Brief: Molecular Targeting of 15-Lipoxygenase-1 (15-LOX-1) for Apoptosis Induction in Human Colorectal 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
Celecoxib Celecoxib 400 mg orally twice daily for 6 months. Up to 23 additional colon tissue biopsies 0 None 2 32 24 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Allergic Reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Bruising SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Flatulance SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal hematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hot flashes SYSTEMATIC_ASSESSMENT General disorders None View
Increase appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bladder infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ear infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Night sweats SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Soar throat SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Boil in left axilla SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Left flank pain SYSTEMATIC_ASSESSMENT General disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View