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 @ 2:33 AM
Ignite Modification Date: 2025-12-26 @ 1:09 AM
NCT ID: NCT00390234
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00390234
Study Brief: Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma
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 (Ziv-aflibercept) Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies None None 29 63 47 63 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Death NOS SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Extraocular muscle paresis SYSTEMATIC_ASSESSMENT Eye disorders None View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Small intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Reversible posterior leukoencephalopathy syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vitreous hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View