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: 2025-12-25 @ 2:53 AM
Ignite Modification Date: 2025-12-26 @ 1:34 AM
NCT ID: NCT04566133
Description: The participants died due to their underlying disease.
Frequency Threshold: 0
Time Frame: Adverse events assessed from the date treatment consent signed to date off study, approximately 3 months and 25 days. Adverse Events monitored/assessed for approximately 3 months and 25 days; All-Cause Mortality monitored/assessed up to 10 months.
Study: NCT04566133
Study Brief: Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC).
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1/Arm 1: Trametinib + Hydroxychloroquine (HCQ) Participants with bile tract carcinoma (BTC) or carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of BTC. Participants receive 2 mg of Trametinib orally once a day of every cycle, and 600 mg of hydroxychloroquine orally twice a day every cycle (1200 mg total dose). 2 None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Skin and subcutaneous tissue disorders - Other, Two small pustule mouth lesions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Belching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Eosinophilia SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (5.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View