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 @ 11:18 PM
Ignite Modification Date: 2025-12-25 @ 8:59 PM
NCT ID: NCT00301756
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00301756
Study Brief: Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors
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 (Enzyme Inhibitor Therapy) Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. None None 12 32 32 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pleural infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View