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 @ 11:11 PM
Ignite Modification Date:
2025-12-25 @ 8:45 PM
NCT ID:
NCT00768469
Description:
Safety Population
Frequency Threshold:
5
Time Frame:
From first dose to last dose plus 28 days, up to 78 weeks.
Study:
NCT00768469
Study Brief:
Study Evaluating Safety And Tolerability, Solid Tumor
Event Groups(If Any):
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Left ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.0) | View |
| Dacryostenosis acquired | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.0) | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.0) | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.0) | View |
| Eye discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.0) | View |
| Eyelid ptosis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.0) | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.0) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.0) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Contrast media allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (17.0) | View |
| Adenoiditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Herpes virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Blood potassium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Brain natriuretic peptide increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Electrocardiogram abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.0) | View |
| Mood altered | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Pharyngeal erythema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Upper respiratory tract inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Prurigo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Skin fissures | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.0) | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.0) | View |