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 @ 3:46 PM
Ignite Modification Date:
2025-12-25 @ 1:53 PM
NCT ID:
NCT00500292
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00500292
Study Brief:
A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of 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 |
|---|---|---|---|---|---|---|---|---|
| Vandetanib 100 mg | vandetanib 100 mg plus FOLFOX | None | None | 6 | 32 | 31 | 32 | View |
| Vandetanib 300 mg | vandetanib 300 mg plus FOLFOX | None | None | 10 | 35 | 32 | 35 | View |
| Placebo | placebo plus FOLFOX | None | None | 4 | 37 | 35 | 37 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 20.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Subileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Mucosal Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 20.0 | View |
| Anaphylactic Reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDra 20.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 20.0 | View |
| Device Related Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 20.0 | View |
| Lung Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 20.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 20.0 | View |
| Staphylococcal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 20.0 | View |
| Staphylococcal Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 20.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 20.0 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 20.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 20.0 | View |
| Adenocarcinoma Gastric | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 20.0 | View |
| Female Genital Tract Fistula | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 20.0 | View |
| Toxic Epidermal Necrolysis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 20.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 20.0 | View |
| Venous Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 20.0 | View |
| Haemorrhage Intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 20.0 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 20.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 20.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 20.0 | View |
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Epigastric Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Gingival Bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Rectal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 20.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 20.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 20.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 20.0 | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 20.0 | View |
| Hepatotoxicity | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 20.0 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 20.0 | View |
| Drug Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDra 20.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 20.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 20.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 20.0 | View |
| Electrocardiogram Qt Prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 20.0 | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 20.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 20.0 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 20.0 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 20.0 | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 20.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 20.0 | View |
| Dysaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 20.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 20.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 20.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 20.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 20.0 | View |
| Peripheral Sensory Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 20.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 20.0 | View |
| Confusional State | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 20.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 20.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 20.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 20.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | View |
| Pharyngolaryngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 20.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 20.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 20.0 | View |
| Dermatitis Acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 20.0 | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 20.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 20.0 | View |
| Palmar-Plantar Erythrodysaesthesia Syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 20.0 | View |
| Photosensitivity Reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 20.0 | View |
| Pigmentation Disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 20.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 20.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 20.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 20.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 20.0 | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 20.0 | View |
| Phlebitis Superficial | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 20.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 20.0 | View |