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 @ 12:34 PM
Ignite Modification Date:
2025-12-25 @ 12:10 PM
NCT ID:
NCT03672461
Description:
None
Frequency Threshold:
0
Time Frame:
9 months
Study:
NCT03672461
Study Brief:
A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Yoga Practice Program | The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. | 0 | None | 1 | 121 | 37 | 121 | View |
| Physical Conditioning Program | The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. | 0 | None | 1 | 119 | 43 | 119 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Recurrent Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.1 | View |
| Detached Retina | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Abdominal Cramps | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Dental Discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Epigastric Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Food Poisoning | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Tooth Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Facial Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 22.1 | View |
| Allergy Nos | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 22.1 | View |
| Hay Fever | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 22.1 | View |
| Bladder Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Coronavirus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Ear Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Lower Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Mumps | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Shingles | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Tooth Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Upper Respiratory Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Back Sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Epicondylitis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Knee Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Lateral Epicondylitis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Leg Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Muscle Strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Pulled Hamstring | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Rib Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Shoulder Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Toe Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Vaccination Adverse Reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Colonoscopy | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Endoscopy | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Back Muscle Spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Back Pain; Knee Injury | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Foot Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Frozen Shoulder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Groin Discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Hand Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Hip Arthrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Hip Discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Knee Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Knee Swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Leg Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Low Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Lumbar Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Muscle Soreness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Pain Ankle | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Pain In Ankle | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Pain In Elbow | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Pain In Hip | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Patellofemoral Pain Syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Rotator Cuff Injury | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Shoulder Deformity Nos | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Shoulder Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Shoulder Soreness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Spinal Disorder Nos | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Melanoma In Situ | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | View |
| Cervical Radiculopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Localised Numbness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Migraine, Unspecified | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Neck Numbness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Sciatica Aggravated | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Stress | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Asthma Aggravated | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Asthmatic Attack | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Shortness Of Breath | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Cyst Epidermal | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Neck Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Back Surgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 22.1 | View |
| Bladder Sling Procedure | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 22.1 | View |
| Bunionectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 22.1 | View |
| Knee Arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 22.1 | View |
| Oral Surgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 22.1 | View |
| Shoulder Replacement | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 22.1 | View |
| Hot Flashes | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |