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:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
NCT ID:
NCT00233402
Description:
None
Frequency Threshold:
2
Time Frame:
30 days
Study:
NCT00233402
Study Brief:
Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Comparator | Standard White Light Cystoscopy | None | None | 32 | 381 | 193 | 381 | View |
| Hexvix Fluorescence Cystoscopy | Standard White Light and Hexvix Fluorescence Cystoscopy | None | None | 39 | 421 | 202 | 421 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Bladder perforation | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Bladder tamponade | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Urinary bladder hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Bladder spasm | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Hemorrhage urinary tract | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Hydronephrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Artrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.0 | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.0 | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.0 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.0 | View |
| Nodal arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.0 | View |
| Epiglottis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.0 | View |
| Pheumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.0 | View |
| Ureteric cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | View |
| Renal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | View |
| Malignant neoplasms benign, malignant and unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.0 | View |
| Beningn prostatic hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 8.0 | View |
| Pelvic pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 8.0 | View |
| Broncospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Hip arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 8.0 | View |
| Cystoprostatectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 8.0 | View |
| Nephrouruterectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 8.0 | View |
| Urinary bladder excision | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 8.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Gravitational edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.0 | View |
| Post procedural pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.0 | View |
| Subdural hematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.0 | View |
| Upper limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.0 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Alcohol withdraw syndrom | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.0 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.0 | View |
| Ischemia | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.0 | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.0 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.0 | View |
| Blood potassium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Normal pressure hydrocephalus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.0 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Cofusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Bladder spasm | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Bladder pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Micturition urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.0 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.0 | View |
| Hypertention | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.0 | View |
| Hypotention | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.0 | View |