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: 2025-12-25 @ 3:13 AM
Ignite Modification Date: 2025-12-26 @ 1:52 AM
NCT ID: NCT05114005
Description: None
Frequency Threshold: 3
Time Frame: Up to 24 weeks
Study: NCT05114005
Study Brief: Tango for Neuropathy Among Breast Cancer Survivors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tango (TEX) The intervention will consist of 16 Argentine Tango (Tango) sessions, adapted for neurorehabilitation per Hackney and Earhart (2010). Delivered over 8 weeks at a frequency of 2x per week and duration of 1 hour per session, this program teaches the basics steps of partnered Tango dance. 0 None 1 26 19 26 View
Home Exercise (HEX) The control group will consist of an evidence-based, structured home exercise program (HEX) based on the 8 week intervention described by Zimmer et al (2018) and recommended by physical therapists specializing in BC within our organization. This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hr training (i.e., endurance, resistance, and sensorimotor) performed 2x per week 0 None 2 26 11 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalized due to low hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Hospitalized due to fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Hospitalized due to fall with broken wrist SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ankle pain (possibly tendonitis per Dr) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Cancer recurrence SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE v.5.0 View
COVID+ SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Fall/LOB- uninjured SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Feeling unwell/ cold SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
GI distress SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Head cold sinuses SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Infection Axilla SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Infection Sinus/Ear SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Planned surgery: chemo port removed SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE v.5.0 View
Planned surgery: melanoma removed SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE v.5.0 View
Plantar fasciitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Poison ivy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Shoulder pain during tango INT SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Sinus infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Stress fracture hip SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Thumb strain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Tripped; would have fallen if son-in-law hadn't caught SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Vaccine reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Walking pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Broken toe SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Endoscopy SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE v.5.0 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Knee arthritis pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Left hip discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Long COVID headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Nerve pain SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Sinus infection and symptoms of POTS SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Steroid injection for foot pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Symptoms of Postural Orthostatic Tachycardia Syndrome (POTS) SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Trauma to toe SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Trigger finger SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View