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 @ 4:16 PM
Ignite Modification Date:
2025-12-25 @ 2:13 PM
NCT ID:
NCT00088166
Description:
Treatment-emergent adverse events (TEAEs) excluded steroid-related conditions noted on the medical history. One patient was randomized to placebo but was administered hCRF instead. For the assessment of safety, the patient data has been included based on the treatment administered rather than that originally randomized.
Frequency Threshold:
5
Time Frame:
Treatment emergent adverse events (TEAEs) were reported at each visit to Week 16
Study:
NCT00088166
Study Brief:
XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| hCRF | Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking. | None | None | 46 | 101 | 99 | 101 | View |
| Placebo | Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking | None | None | 40 | 99 | 97 | 99 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Heparin-induced thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.1 | View |
| Blindness | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.1 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Ileus paralytic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Biliary colic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 10.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Brain abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Respiratory Tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Cervical vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Radiation injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Traumatic brain injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Hyponataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| Breast cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| Glioblastoma multiforme | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| Metastases to meninges | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| Metastatic neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| Neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| Non-small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Brain oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Grand mal convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Intracranial hypotension | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Metabolic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Partial seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Respiratory depression | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Venous thrombosis limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Large cell carcinoma respiratory tract | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| Cerebral schaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Mental disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.1 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.1 | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| COPD | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Insmnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| myopathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 10.1 | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Partial seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Cushingoid | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 10.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.1 | View |
| Brain oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |
| Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.1 | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.1 | View |