Adverse Events Module

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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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT02348112
Description: None
Frequency Threshold: 1
Time Frame: Adverse event data was collected through 36 months.
Study: NCT02348112
Study Brief: Altis® 522 Trial - Treatment of Female Stress Urinary 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
Altis Arm Subjects will have an Altis sling placed to treat stress urinary incontinence. 0 None 24 184 74 184 View
Comparator Arm Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence. 1 None 29 171 66 171 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bleeding, hematoma or hemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Delayed wound healing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mesh exposure (extrusion) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Shortness of breath, chest pain, L jaw/neck pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pelvic / urogenital pain (groin) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Perforation, bladder SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urinary retention/obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Abdominal Abscess following appendectomy SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute pancreatitis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Acute renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Adenomyosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Appendicitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Broke left arm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Broke right arm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Broken left ankle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Broken right ankle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cervical Spinal Stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Diverticular stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elective surgery of total prosthesis right knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Exacerbation of COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Femur fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intra-abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Left Carotid Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Left Humerus Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Metastatic cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Morbid Obesity SYSTEMATIC_ASSESSMENT General disorders None View
Non STEMI myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Parastomal abscess and cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Paroxysmal Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Partial small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Patient hurt her shoulder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Perianal abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pre-Cancerous Cells Removed From Left Breast SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Rectal Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retro-sternal pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right Elbow fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right Shoulder Reconstructive Surgery SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right bimalleolar ankle fracture, fibular fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right carpal tunnel release surgery SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Small bowel obstruction and fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thoracic Degenerative Discs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Total right knee prothesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Worsening Right knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abnormal cardiac stress test SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abnormal mammogram SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bilateral knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Drug overdose SYSTEMATIC_ASSESSMENT General disorders None View
Endometrial cancer SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Increased blood sugars SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Left femur fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Medial meniscus tear of right knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ocular migraine SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary thromboembolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Recurrent gluteus Medius tear SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right coronary occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right index finger and thumb injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Spinal cord stimulator SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Total left knee prothesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Unstable angina / chest pains SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Wound necrosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary retention/obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pelvic / urogenital pain (groin) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspareunia, de novo SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hip and leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Recurrent incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspareunia, worsening SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Urgency, worsening SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urgency, de novo SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View