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 @ 3:20 AM
Ignite Modification Date: 2025-12-26 @ 1:58 AM
NCT ID: NCT00866905
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00866905
Study Brief: Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast 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
Ixabepilone/Cyclophosphamide All patients who received a dose of study treatment None None 6 168 167 168 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v 4.0 View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
ENTERITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
PERIPHERAL NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
ALLERGIC REACTION SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v 4.0 View
ALLERGIC RHINITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
ANEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
ANOREXIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v 4.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
BONE PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
BREAST PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v 4.0 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v 4.0 View
DIARRHEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
DYSPNEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
EDEMA SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
HYPERGLYCEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 4.0 View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v 4.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v 4.0 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
MUCOSITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
NAIL CHANGES SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
PAIN SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
PARESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
PERIPHERAL NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
TASTE ALTERATION SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
UPPER RESPIRATORY INFECTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
WEIGHT LOSS SYSTEMATIC_ASSESSMENT Investigations CTCAE v 4.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
FEVER SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
HOT FLASHES SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v 4.0 View
SORE THROAT SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View