Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:47 PM
Ignite Modification Date: 2025-12-25 @ 3:14 PM
NCT ID: NCT01613768
Description: Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
Frequency Threshold: 5
Time Frame: Adverse events collected from the time patient received the first dose of study therapy through 36 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 36 days post therapy.
Study: NCT01613768
Study Brief: Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer
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 (Eribulin Mesylate) Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. 0 None 3 29 16 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Pathological spinal fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View