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 @ 11:29 PM
Ignite Modification Date: 2025-12-25 @ 9:16 PM
NCT ID: NCT01510756
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01510756
Study Brief: Sorafenib for the Treatment of Chronic Lymphocytic Leukemia (CLL)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sorafenib Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles. None None 1 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Brain abscess (aspergillus) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Amylase elevation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Hand foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
hyperbillirubinema SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Lipase elevation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View