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 @ 2:22 AM
Ignite Modification Date: 2025-12-26 @ 12:53 AM
NCT ID: NCT00063934
Description: None
Frequency Threshold: 5
Time Frame: 2 years and 5 months
Study: NCT00063934
Study Brief: Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced 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
Oblimersen Plus Doxorubicin + Docetaxel Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m\^2 and Docetaxel 75 mg/m\^2 infused on Day 6 1 None 30 30 30 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection, non-neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Infection or fever with Neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Fatigue SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (2.0) View
Death SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Drug fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Rash/Desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Heartburn/Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Ocular/Vision (other) SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View
Pruritis/Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Alanine aminotransferase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View