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 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
NCT ID:
NCT00520403
Description:
AE (serious and non-serious) information was collected for participants in the Safety Population and reported for the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine).
Frequency Threshold:
0
Time Frame:
From treatment start to 28 days after treatment cessation in the regular treatment period only (Cycles 1 through 17; bevacizumab + IFN/vinblastine). Does not include AEs reported during bevacizumab monotherapy (Cycles 18 and beyond).
Study:
NCT00520403
Study Brief:
A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell 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 |
|---|---|---|---|---|---|---|---|---|
| Bevacizumab + IFN/Vinblastine | Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3). Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression. If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression. | None | None | 8 | 25 | 22 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.1) | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| General Physical Health Deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Injection Site Reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Systemic Inflammatory Response Syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Cerebral Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.1) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.1) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.1) | View |
| Pancytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.1) | View |
| Arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.1) | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.1) | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.1) | View |
| Abdominal pain lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Ileus paralytic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Loose tooth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Tongue ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Drug intolerance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Impaired healing | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Abscess jaw | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Postoperative hernia | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Blood sodium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| Intraocular pressure test | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| Urine output decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Iron deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Bursitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Fascial hernia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Groin pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Osteonecrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Depressed mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| Restlessness | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| Sleep disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Nasal dryness | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Nocturnal dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Nail disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Scar pain | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Skin atrophy | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.1) | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.1) | View |