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:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT00503906
Description:
None
Frequency Threshold:
3
Time Frame:
None
Study:
NCT00503906
Study Brief:
Abraxane, Avastin, and Gemcitabine as First-Line Therapy 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 |
|---|---|---|---|---|---|---|---|---|
| Abraxane, Avastin and Gemcitabine | Each treatment cycle is 28 days. Participants will be treated until disease progression: * Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by; * Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by; * Avastin: 10 mg/kg IV on days 1 and 15 of each cycle. | None | None | 8 | 29 | 29 | 29 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Peripheral Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| PortAcath infection | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Breast Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Fever/Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Neutropenic Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Seizure/Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Tamponade | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (3.0) | View |
| UTI | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Skin rash/lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hand/Foot syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Peripheral Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| PortAcath Disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Amenorrhea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Blurred Vision | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Flu-like symptoms | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Loss of appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Lymphedema | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Oral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Rhinorrhea | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Skin discoloration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Weight Loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Acute renal insufficiency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Heat intolerance | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (3.0) | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Painful edema | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Pedal edema | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Reflux | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Regurgitation (valve) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Scotoma | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Thrombus | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Tricuspid Regurg | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |