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: 2025-12-24 @ 6:26 PM
Ignite Modification Date: 2025-12-25 @ 3:56 PM
NCT ID: NCT01917968
Description: None
Frequency Threshold: 0
Time Frame: 36 Months
Study: NCT01917968
Study Brief: Uphold LITE Post-Market Surveillance 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
Uphold Lightweight Vaginal Support System Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE) 3 None 12 225 108 225 View
Traditional Native Tissue Repair Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy 2 None 27 485 312 485 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Event- New SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Event- Worsening SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation - Worsening SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus / Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other, Specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Infection- Other, Specify Type SYSTEMATIC_ASSESSMENT General disorders None View
Infection - Other, specify type SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pelvic Infection / Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary Event, Specify - NEW SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection (UTI), Lower SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ureteral Kink / Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Visceral Organ Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other, Specify SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Mesh Exposure in Vagina SYSTEMATIC_ASSESSMENT Product Issues None View
Hematoma - Retropubic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Mixed Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pelvic Pain - NEW SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pulmonary Event, Specify - Worsening SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other, Specify SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bleeding Requiring Blood Transfusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Malignant Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombotic Event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cardiac Event - NEW SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Worsening SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation - NEW SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation - Worsening SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fecal Incontinence - NEW SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fecal Incontinence - Worsening SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoma - Retroperitoneal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus / Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neuromuscular Disorder, specify type SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other, Specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Neuromuscular Disorder, specify type SYSTEMATIC_ASSESSMENT General disorders None View
Other, Specify SYSTEMATIC_ASSESSMENT General disorders None View
Pain, Other SYSTEMATIC_ASSESSMENT General disorders None View
Infection - Other, specify type SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other, Specify SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pelvic Infection / Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary Event, Specify - NEW SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection (UTI), Lower SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other, Specify SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Visceral Organ Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Buttock Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neuromuscular Disorder, specify type SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasia, Non-Pelvic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Neuromuscular Disorder, specify type SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurovascular Event SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mesh Exposure in Vagina SYSTEMATIC_ASSESSMENT Product Issues None View
Suture Exposure in Vagina SYSTEMATIC_ASSESSMENT Product Issues None View
Difficulty Emptying Bladder - NEW SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Difficulty Emptying Bladder - Worsening SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Mixed Incontinence- Worsening SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Mixed Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other, Specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Overactive Bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Stress Incontinence - NEW SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Stress Incontinence - Worsening SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urge Incontinence - NEW SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urge Incontinence - Worsening SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Weak Urinary Stream SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspareunia - NEW (De Novo) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dyspareunia - Worsening SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hematoma - Vaginal SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other, Specify SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pelvic Pain - New SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pelvic Pain - Worsening SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Sensation Of Bulge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Sensation Of Pressure SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal Atrophy SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal Bleeding, De Novo SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal Discharge, Atypical SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal Scarring SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal Shortening SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal Wall Dehiscence SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vulvar Itching SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vulvar Lesion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other, Specify SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lichen Sclerosus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Condition SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tissue Granulation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hematoma - Other SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other, Specify SYSTEMATIC_ASSESSMENT Vascular disorders None View