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 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
NCT ID:
NCT00434356
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00434356
Study Brief:
A Study of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer (SABRE-B)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Bevacizumab + Paclitaxel + Sunitinib | Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest | None | None | 10 | 23 | 21 | 23 | View |
| Bevacizumab + Paclitaxel | Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest | None | None | 9 | 23 | 18 | 23 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Hemolytic Anemia | None | Blood and lymphatic system disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Gastrointestinal Perforatioin | None | Gastrointestinal disorders | None | View |
| Hemorrhoids | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Chest Pain | None | General disorders | None | View |
| Asthenia | None | General disorders | None | View |
| Drug Hypersensitivity | None | Immune system disorders | None | View |
| Anaphylactic Reaction | None | Immune system disorders | None | View |
| Upper Respiratory Tract Infection | None | Infections and infestations | None | View |
| Cellulitis | None | Immune system disorders | None | View |
| Tooth Infection | None | Immune system disorders | None | View |
| Pneumonia | None | Infections and infestations | None | View |
| Spinal Compression Fracture | None | Injury, poisoning and procedural complications | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Hypoglycemia | None | Metabolism and nutrition disorders | None | View |
| Syncope | None | Nervous system disorders | None | View |
| Pulmonary Embolism | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin Ulcer | None | Skin and subcutaneous tissue disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Leukopenia | None | Blood and lymphatic system disorders | None | View |
| Febrile Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia | None | Blood and lymphatic system disorders | None | View |
| Diarrhoea | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Hyperbilirubinemia | None | Hepatobiliary disorders | None | View |
| Otitis Media | None | Infections and infestations | None | View |
| Rhinitis | None | Infections and infestations | None | View |
| Skin Infection | None | Infections and infestations | None | View |
| Urinary Tract Infection | None | Infections and infestations | None | View |
| Thermal Burn | None | Injury, poisoning and procedural complications | None | View |
| Hemoglobin Decreased | None | Investigations | None | View |
| Neutrophil Count Decreased | None | Investigations | None | View |
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Memory Impairment | None | Nervous system disorders | None | View |
| Migraine | None | Nervous system disorders | None | View |
| Confusional State | None | Psychiatric disorders | None | View |
| Hematuria | None | Renal and urinary disorders | None | View |
| Proteinuria | None | Renal and urinary disorders | None | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hemoptysis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Dermatitis | None | Skin and subcutaneous tissue disorders | None | View |
| Palmar-Plantar Erythrodysasthesia Syndrome | None | Skin and subcutaneous tissue disorders | None | View |
| Lymphopenia | None | Blood and lymphatic system disorders | None | View |
| Tachycardia | None | Cardiac disorders | None | View |
| Oral Discomfort | None | Gastrointestinal disorders | None | View |
| Stomatitis | None | Gastrointestinal disorders | None | View |
| Pain | None | General disorders | None | View |
| Pyrexia | None | General disorders | None | View |
| Infection | None | Infections and infestations | None | View |
| Weight Decreased | None | Investigations | None | View |
| Musculoskeletal Chest Pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Metastases to Liver | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Hypoaesthesia | None | Nervous system disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Neuropathy Peripheral | None | Nervous system disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Gingival Bleeding | None | Gastrointestinal disorders | None | View |
| Small Intestinal Obstruction | None | Gastrointestinal disorders | None | View |
| Toothache | None | Gastrointestinal disorders | None | View |
| Mucosal Inflammation | None | General disorders | None | View |
| Hypertension | None | Vascular disorders | None | View |