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 @ 4:27 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT00377520
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00377520
Study Brief: A Trial for Patients With Advanced/Recurrent Endometrial 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
Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression None None 6 26 26 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Gastrointestinal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Lymphatics SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Ocular SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Constitutional SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Serum glutamic-oxaloacetic transaminase SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Metabolic SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Neurologic SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dermatologic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View