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 @ 7:47 PM
Ignite Modification Date: 2025-12-25 @ 5:24 PM
NCT ID: NCT00295503
Description: None
Frequency Threshold: 1.5
Time Frame: 3 years 6 months
Study: NCT00295503
Study Brief: Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Arm cisplatin, pemetrexed, and bevacizumab None None 16 53 24 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pulmonary embolus NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
deep venous thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
RPLS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
small bowel obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
neutropenic fever NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
squamous cell carcinoma of the skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View