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 @ 2:25 AM
Ignite Modification Date:
2025-12-26 @ 12:58 AM
NCT ID:
NCT02221934
Description:
None
Frequency Threshold:
5
Time Frame:
From time of lidocaine injection screening through Month-12, approximately 1 year
Study:
NCT02221934
Study Brief:
Electrical Nerve Block for Amputation Pain
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Active Sham Control Treatment | Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius. | 2 | None | 35 | 85 | 34 | 85 | View |
| Test Treatment | Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius. | 1 | None | 35 | 85 | 34 | 85 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Atrial flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Cardiac tamponade | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| Adverse drug reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Implant site necrosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Medical device discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Medical device site discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Medical device site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Hepatic cirrhosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (21.0) | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Rotavirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.0) | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.0) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Corona virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Implant site cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Implant site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Incision site abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Shunt infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Cervical vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Incision site haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Limb injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Limb traumatic amputation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Procedural complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Subdural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Tendon injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.0) | View |
| Diabetic ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | View |
| Rhabdomyolysis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | View |
| Rotator cuff syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | View |
| Calcifying fibrous pseudotumour | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | View |
| Colon cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | View |
| Neuroma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | View |
| Osteosarcoma metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | View |
| Amputation stump pain | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| Toxic encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| Device extrusion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (21.0) | View |
| Major depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (21.0) | View |
| Mental status changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (21.0) | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.0) | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (21.0) | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | View |
| Pneumonia aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | View |
| Respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | View |
| Amputation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (21.0) | View |
| Knee operation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (21.0) | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.0) | View |
| Peripheral ischaemia | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.0) | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.0) | View |
| Pericardial effusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| Haematemesis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| Atrioventricular block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (21.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Medical device discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| Corona virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | View |