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 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
NCT ID:
NCT00593827
Description:
AEs and other symptoms were graded according to the CTCAE Version 3.0 and categorized according to Medical Dictionary for Regulatory Activities (MedDRA) Version 14.1.
Frequency Threshold:
5
Time Frame:
From the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m2 arm; 3-87 weeks for 40 mg/m2 arm).
Study:
NCT00593827
Study Brief:
Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With 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 |
|---|---|---|---|---|---|---|---|---|
| Ixabepilone 16 mg/m^2 | ixabepilone 16 mg/m\^2 weekly for 3 weeks followed by 1 week rest | None | None | 25 | 82 | 82 | 82 | View |
| Ixabepilone 40 mg/m^2 | ixabepilone 40 mg/m\^2 every 3 weeks | None | None | 30 | 89 | 89 | 89 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| effusion pleural | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| distress respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| embolus pulmonary | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| failure respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| infection bladder | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| fibrillation atrial | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| angina attack | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| congestive heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| flutter atrial | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| arrest cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| cardiopulmonary arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| weakness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| gastroparesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| electrolyte abnormality | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| gastrointestinal bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| glucose blood increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| fracture pathological | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| pain bone | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 14.1 | View |
| neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| leucopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| weakness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| weight loss | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| dysguesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| gastroesophageal reflux | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| mucositis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| infection fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| pain bone | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.1 | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| infection upper respiratory | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| infection bladder | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |