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 @ 10:02 PM
Ignite Modification Date: 2025-12-25 @ 7:39 PM
NCT ID: NCT01033032
Description: All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Frequency Threshold: 5
Time Frame: every 3 weeks up to 43 months
Study: NCT01033032
Study Brief: Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic 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
Dose Level 3 (MTD)/Phase II Amrubicin - 110 mg/m\^2 by intravenous (IV) every 21 days Includes patients treated at the MTD in Dose Level 3 phase 1 and in phase II None None 5 66 65 66 View
Dose Level 1 Amrubicin - 90 mg/m\^2 by intravenous (IV) every 21 days None None 1 3 3 3 View
Dose Level 2 Amrubicin - 100 mg/m\^2 by intravenous (IV) every 21 days None None 0 3 3 3 View
Dose Level 4 Amrubicin - 120 mg/m\^2 by intravenous (IV) every 21 days None None 1 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View
LYMPH NODE PAIN SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
NEUTROPHIL COUNT DECREASED SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v 4.0 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
PNEUMONITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v 4.0 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
PULMONARY INFILTERATES SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal 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
ALKALINE PHOSPHATASE INCREASED SYSTEMATIC_ASSESSMENT Investigations 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
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v 4.0 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations 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
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
DECREASED BREATH SOUNDS 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
DYSGEUSIA 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
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
HYPERGLYCEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v 4.0 View
HYPOKALEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 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
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v 4.0 View
NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v 4.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v 4.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue 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
PAIN SYSTEMATIC_ASSESSMENT General disorders CTCAE v 4.0 View