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 @ 9:42 PM
Ignite Modification Date: 2025-12-25 @ 7:23 PM
NCT ID: NCT00553332
Description: None
Frequency Threshold: 5
Time Frame: All patients were evaluated for toxicity using the NCI Common Toxicity Criteria version 3.0 from the time of their first treatment until the end of treatment.
Study: NCT00553332
Study Brief: Selumetinib in Treating Patients With Biliary Cancer That Cannot Be Removed By Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Enzyme Inhibitor Therapy) Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. selumetinib: Given orally laboratory biomarker analysis: Correlative studies None None 0 28 28 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 3.0 View
Xerostomia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 3.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 3.0 View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE version 3.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 3.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE version 3.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 3.0 View