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 @ 12:21 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT00738361
Description: The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Frequency Threshold: 5
Time Frame: None
Study: NCT00738361
Study Brief: Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NAb-paclitaxel Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days. None None 0 4 4 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE Version 3 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE Version 3 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE Version 3 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 3 View
Creatinine SYSTEMATIC_ASSESSMENT Investigations CTCAE Version 3 View
Dermatology Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE Version 3 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 3 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE Version 3 View
Dry mouth/salivary gland (xerostomia) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 3 View
Dyspnea (shortness of breath) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE Version 3 View
Edema: limb SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 3 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE Version 3 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 3 View
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) SYSTEMATIC_ASSESSMENT General disorders CTCAE Version 3 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 3 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE Version 3 View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE Version 3 View
Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 3 View
Hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE Version 3 View
Hemorrhage, pulmonary/upper respiratory - Nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE Version 3 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE Version 3 View
Infection with normal ANC or Grade 1 or 2 neutrophils SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE Version 3 View
Infection with normal ANC or Grade 1 or 2 neutrophils SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE Version 3 View
Infection with normal ANC or Grade 1 or 2 neutrophils SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE Version 3 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE Version 3 View
Leukocytes (total WBC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE Version 3 View
Venous insuffiency SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE Version 3 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE Version 3 View
Alanine Aminotransferase (ALT) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE Version 3 View
Aspartate aminotransferase (AST) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE Version 3 View
Infection with Normal ANC or Grade 1 or 2 Neutrophils SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE Version 3 View
Infection with normal ANC or Grade 1 or 2 Neutrophils SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE Version 3 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE Version 3 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE Version 3 View
Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE Version 3 View