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 @ 5:05 PM
Ignite Modification Date:
2025-12-25 @ 2:44 PM
NCT ID:
NCT01294150
Description:
All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
Frequency Threshold:
5
Time Frame:
Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit.
Study:
NCT01294150
Study Brief:
The Safety and Effectiveness of UroLift: LIFT Pivotal Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| UroLift System | The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule. | 9 | None | 52 | 140 | 133 | 140 | View |
| Crossover | Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months. | 4 | None | 19 | 53 | 49 | 53 | View |
| Cystoscopy | The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months. | 0 | None | 0 | 13 | 0 | 13 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Haematuria | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.1) | View |
| Arteriovenous fistula | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.1) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.1) | View |
| Calculus urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Cataract operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.1) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Coronary artery bypass | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.1) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.1) | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Embolism pulmonary | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Gastrointestinal stromal tumour | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Hepatic cirrhosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (13.1) | View |
| Hip arthroplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| Ischaemic cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.1) | View |
| Joint arthroplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| Leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Metastatic renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Metastatic squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.1) | View |
| Nasal septum deviation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Pancreatic carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| Pancreatitis chronic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| Peripheral vascular disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.1) | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| Renal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Renal cancer metastatic | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Residual urine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Thyroid disorder | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (13.1) | View |
| Transient global amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Venous insufficiency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.1) | View |
| Whiplash injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.1) | View |
| Carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Facial bones fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| Head and neck cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Knee arthroplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| Multiple myeloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Testicular injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| Urine flow decreased | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Other, L2 Paraganglioma WHO grade 1 | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Coronary Arterial Stent Insertion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Transurethral prostatectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (13.1) | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.1) | View |
| Spinal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Micturation Urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Pelvic Pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Urinary Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Urinary Retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Calculus urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Prostatic specific antigen increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.1) | View |
| Residual urine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |