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 @ 4:01 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT00112866
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT00112866
Study Brief: Cilengitide in Treating Patients Who Are Undergoing Surgery for Recurrent or Progressive Glioblastoma Multiforme
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Post-Operative 2000mg Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity. cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies None None 0 26 26 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
bruising NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
hemoglobin NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
neutrophils NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
platelets NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Alanine aminotransferase NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View