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 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
NCT ID:
NCT00025233
Description:
None
Frequency Threshold:
0
Time Frame:
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Study:
NCT00025233
Study Brief:
Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
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 | Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy | None | None | 27 | 46 | 46 | 46 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Constitutional Symptoms Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Nail Changes | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Diarrhea Without Colostomy | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Melena/Gi Bleeding | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Vaginal Bleeding | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Mood Alteration Depression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (2.0) | View |
| Creatinine | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Sinus Tachychardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Pelvic Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Bone Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Renal/Gu Other | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Rectal Bleeding/Hematochezia | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Thrombosis Embolism | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pain other | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Infection With Grade 3/4 Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Ureteral Obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (2.0) | View |
| Allergic Reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (2.0) | View |
| Inner Ear/Hearing | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (2.0) | View |
| Middle Ear/Hearing | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (2.0) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Transfusion Prbc's | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Transfusion Platelets | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Lymphatics Other | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (2.0) | View |
| Cardiac Left Ventricular Function | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Sinus Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Arrhythmia Nodal/Junctional Dysrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Edema | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Thrombosis Embolism | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (2.0) | View |
| Prothrombin Time | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Coagulation Other | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Partial Thromboplastin Time | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Rectal Bleeding/Hematochezia | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Vaginal Bleeding | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Hematuria No Vaginal Bleeding | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Hemoptysis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (2.0) | View |
| Fever(No Neutropenia) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Weight Loss | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Rigors Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Constitutional Symptoms Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Sweating | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pain Other | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pain Tumor | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Neuropathic Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Earache | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Dyspareunia | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pelvic Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Bone Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pain Rectal/Perirectal | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (2.0) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Rash Desquamation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Skin Other | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Nail Changes | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Wound Not-Infectious | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Pigmentation Changes | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Wound Infectious | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Bruising | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (2.0) | View |
| Hot Flashes/Flushes | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (2.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Fistula Intestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Mouth Dryness | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Proctitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Dyspepsia/Heartburn | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Fistula Rectal/Anal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Taste Disturbance | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Diarrhea Without Colostomy | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Stomatitis/Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Gi Other | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (2.0) | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Alkaline Phosphatase | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Bilirubin | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Infection No Anc | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Infection Without Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (2.0) | View |
| Metabolic Other | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Bicarbonate | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypernatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypermagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypercalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Hypomagnesmia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Muscle Weakness | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Speech Impairment | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Hallucinations | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Extrapyramidal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Depressed Level Of Consciousness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Mood Alteration Anxiety/Agitation | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Memory Loss | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Mood Alteration Depression | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Neuropathy Sensor | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Neuropathy Motor | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | View |
| Ocular Other | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Tearing | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Vision Flashing Lights/Floaters | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Double Vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (2.0) | View |
| Voice Changes/Stridor/Larynx | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | View |
| Urinary Frequency/Urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Creatinine | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Renal/Gu Other | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Ureteral Obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Hemoglobinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Fistula | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Bladder Spasms | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |
| Libido | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (2.0) | View |
| Sgot(Alt) | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Sgot(Ast) | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (2.0) | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (2.0) | View |
| Urinary Retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (2.0) | View |