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 @ 7:10 PM
Ignite Modification Date:
2025-12-25 @ 4:45 PM
NCT ID:
NCT00642603
Description:
Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00642603
Study Brief:
A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal 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 |
|---|---|---|---|---|---|---|---|---|
| XELOX + Bevacizumab (Q2W) | Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment. | None | None | 4 | 19 | 17 | 19 | View |
| XELIRI + Bevacizumab (Q2W) | Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment. | None | None | 7 | 20 | 19 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Intestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Clostridium Difficile Colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Hypertrophic Cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Rhabdomyolysis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Lacunar Infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Angioedema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Deep Vein Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neuropathy Peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system 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 |
| Burning Sensation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Disturbance In Attention | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Alopecia | 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 |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Livedo Reticularis | 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 |
| Night Sweats | 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 |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Food Intolerance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Cough | 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 |
| Dyspnoea Exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Dysaesthesia Pharynx | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Respiratory Tract Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Abscess Intestinal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Clostridial Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Clostridium Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Escherichia Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Gastrointestinal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Vulvovaginal Mycotic Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Musculoskeletal Pain | 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 |
| Muscle Spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Musculoskeletal Stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Neck Pain | 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 |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.1) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.1) | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| Blood Creatinine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| Sputum Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| X-ray Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.1) | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.1) | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.1) | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.1) | View |
| Vision Blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.1) | View |
| Tooth Extraction | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (10.1) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.1) | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Paraesthesia Oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Rectal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Catheter Related Complication | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Catheter Thrombosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Gait Disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Influenza Like Illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Infusion Related Reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Mucosal Inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Temperature Intolerance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Peripheral Motor Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Restless Legs Syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Palmar-Plantar Erythrodysaesthesia Syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Diarrhoea | 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 |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Oral Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Abdominal Discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Anal Pruritus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Gastrointestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Gingival Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |