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 @ 6:55 PM
Ignite Modification Date:
2025-12-25 @ 4:28 PM
NCT ID:
NCT00200057
Description:
Adverse events listed below were collected after permanent implant of the device through the data cutoff date.
Frequency Threshold:
5
Time Frame:
One hundred twenty subjects were implanted with the InterStim system, accumulating 2758 device months of experience (ranging from 2.2 to 61 months, averaging 23 months) through the data cutoff date of May 27, 2008.
Study:
NCT00200057
Study Brief:
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Implanted Subjects | Subjects implanted with Sacral Nerve Stimulation (SNS) device. | None | None | 41 | 120 | 88 | 120 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Implant site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Perianal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Benign neoplasm of adrenal gland | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Breast cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Electrolyte imbalance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| Delirium | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| Eating disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Carotid artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Cervical myelopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Varicose vein | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Pleurisy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Proctalgia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Rectal prolapse | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Duodenitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Volvulus of bowel | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (8.0) | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (8.0) | View |
| Skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Renal failure chronic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Vaginal pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (8.0) | View |
| Implant site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Therapeutic product ineffective | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Implant site erosion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Ulcer | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Seroma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Spinal fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Knee arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (8.0) | View |
| Lead migration/dislodgment | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Implant site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Implant site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Faecal incontinence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Proctalgia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Laboratory test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.0) | View |
| Change in sensation of stimulation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |