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 @ 3:06 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT02367859
Description: None
Frequency Threshold: 0
Time Frame: 6 weeks
Study: NCT02367859
Study Brief: Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma
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 (Dabrafenib) Patients receive dabrafenib orally twice daily every 12 hours plus trametinib daily orally for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients whose disease is judged to be not amenable to resection will continue dabrafenib and trametinib indefinitely as long as there has not been tumor progression. 0 None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v (4.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v (4.0) View
Rash acneform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v(4.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE v(4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v(4.0) View
Dermatologic syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v (4.0) View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE v (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v (4.0) View